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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00289783

Registration number

NCT00289783

Ethics application status

Date submitted

9/02/2006

Date registered

10/02/2006

Date last updated

24/08/2018

Titles & IDs

Public title

Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Scientific title

A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Secondary ID [1]

105067

Secondary ID [2]

103813

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Haemophilus Influenzae Type b

Neisseria Meningitidis

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Other - GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
Treatment: Other - ActHIB
Treatment: Other - PedvaxHIB
Treatment: Other - Pediarix
Treatment: Other - Prevnar
Treatment: Other - M-M-R II
Treatment: Other - Varivax

Experimental: Menhibrix A Group - Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Experimental: Menhibrix B Group - Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Experimental: Menhibrix C Group - Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Experimental: Menhibrix Group - Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Active comparator: ActHIB Group - Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Treatment: Other: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

Treatment: Other: ActHIB
3-dose intramuscular injection at 2, 4 and 6 months of age.

Treatment: Other: PedvaxHIB
1 booster dose by intramuscular injection at 12 to 15 months of age.

Treatment: Other: Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.

Treatment: Other: Prevnar
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

Treatment: Other: M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.

Treatment: Other: Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations

Timepoint [1]

One month after primary vaccination

Primary outcome [2]

Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

Timepoint [2]

One month after primary vaccination

Primary outcome [3]

Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

Timepoint [3]

One month after primary vaccination

Primary outcome [4]

hSBA-MenC Antibody Titers

Timepoint [4]

Prior to the fourth dose vaccination and 42 days after the fourth dose

Primary outcome [5]

hSBA-MenY Antibody Titers

Timepoint [5]

Prior to the fourth dose vaccination and 42 days after the fourth dose

Primary outcome [6]

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)

Timepoint [6]

One month after primary vaccination

Primary outcome [7]

Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8

Timepoint [7]

42 days after the fourth dose

Primary outcome [8]

Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8

Timepoint [8]

42 days after the fourth dose

Primary outcome [9]

Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)

Timepoint [9]

42 days after the fourth dose

Primary outcome [10]

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter

Timepoint [10]

42 days after the fourth dose

Primary outcome [11]

Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)

Timepoint [11]

42 days after the fourth dose

Primary outcome [12]

Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)

Timepoint [12]

42 days after the fourth dose

Primary outcome [13]

Number of Subjects With Anti-varicella Titer Equal to or Above 1:5

Timepoint [13]

42 days after the fourth dose

Secondary outcome [1]

Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)

Timepoint [1]

One month after primary vaccination

Secondary outcome [2]

Anti-D and Anti-T Antibody Concentrations

Timepoint [2]

One month after primary vaccination

Secondary outcome [3]

Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)

Timepoint [3]

One month after primary vaccination

Secondary outcome [4]

Anti-HBS Antibody Concentrations

Timepoint [4]

One month after primary vaccination

Secondary outcome [5]

Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)

Timepoint [5]

One month after primary vaccination

Secondary outcome [6]

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

Timepoint [6]

One month after primary vaccination

Secondary outcome [7]

Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)

Timepoint [7]

One month after primary vaccination

Secondary outcome [8]

Anti-poliovirus Types 1, 2 and 3 Titers

Timepoint [8]

One month after primary vaccination

Secondary outcome [9]

Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values

Timepoint [9]

One month after primary vaccination

Secondary outcome [10]

Anti-PSC and Anti-PSY Antibody Concentrations

Timepoint [10]

One month after primary vaccination

Secondary outcome [11]

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values

Timepoint [11]

One month after the primary vaccination course

Secondary outcome [12]

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values

Timepoint [12]

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Secondary outcome [13]

Anti-PRP Antibody Concentrations

Timepoint [13]

One month after the primary vaccination course

Secondary outcome [14]

Anti-PRP Antibody Concentrations

Timepoint [14]

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Secondary outcome [15]

Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values

Timepoint [15]

One month after the primary vaccination course

Secondary outcome [16]

Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values

Timepoint [16]

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Secondary outcome [17]

hSBA-MenC and hSBA-MenY Antibody Titers

Timepoint [17]

One month after the primary vaccination course

Secondary outcome [18]

hSBA-MenC and hSBA-MenY Antibody Titers

Timepoint [18]

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Secondary outcome [19]

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Timepoint [19]

One month after the primary vaccination course

Secondary outcome [20]

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Timepoint [20]

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Secondary outcome [21]

Anti-PSC and Anti-PSY Antibodies Concentrations

Timepoint [21]

One month after the primary vaccination course

Secondary outcome [22]

Anti-PSC and Anti-PSY Antibody Concentrations

Timepoint [22]

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Secondary outcome [23]

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value

Timepoint [23]

One month after the primary vaccination course

Secondary outcome [24]

Anti-PRP Antibody Concentrations

Timepoint [24]

One month after the primary vaccination course and prior to the fourth dose vaccination

Secondary outcome [25]

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values

Timepoint [25]

One month after the primary vaccination course

Secondary outcome [26]

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Timepoint [26]

Prior to the fourth dose vaccination and 42 days after fourth dose vaccination

Secondary outcome [27]

Anti-PSC and Anti-PSY Antibody Concentrations

Timepoint [27]

Prior to the fourth dose vaccination and 42 days after fourth dose vaccination

Secondary outcome [28]

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)

Timepoint [28]

Prior to the fourth dose vaccination and 42 days after fourth vaccination

Secondary outcome [29]

Anti-PRP Antibody Concentrations

Timepoint [29]

Prior to the fourth vaccination and 42 days after fourth vaccination

Secondary outcome [30]

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4

Timepoint [30]

Prior to the fourth dose vaccination and 42 days after fourth vaccination

Secondary outcome [31]

Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)

Timepoint [31]

42 days after fourth vaccination

Secondary outcome [32]

Anti-measles Antibody Concentrations

Timepoint [32]

42 days after fourth vaccination

Secondary outcome [33]

Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values

Timepoint [33]

42 days after fourth vaccination

Secondary outcome [34]

Anti-mumps Antibody Titers

Timepoint [34]

42 days after fourth vaccination

Secondary outcome [35]

Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)

Timepoint [35]

42 days after fourth vaccination

Secondary outcome [36]

Anti-rubella Antibody Concentrations

Timepoint [36]

42 days after fourth vaccination

Secondary outcome [37]

Number of Subjects With Anti-varicella Titer Equal to or Above 1:40

Timepoint [37]

42 days after fourth vaccination

Secondary outcome [38]

Anti-varicella Antibody Titers

Timepoint [38]

42 days after fourth vaccination

Secondary outcome [39]

Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40

Timepoint [39]

Prior to the fourth dose vaccination and one month after the fourth dose vaccination

Secondary outcome [40]

Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit

Timepoint [40]

In the 4-day (Day 0-3) follow-up period after primary vaccination course

Secondary outcome [41]

Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit

Timepoint [41]

In the 4-day (Day0-3) follow-up period after the fourth dose

Secondary outcome [42]

Number of Subjects Reporting Solicited Local and General Symptoms

Timepoint [42]

Within the 4 days (Day 0-3) following each dose of the primary vaccination course

Secondary outcome [43]

Number of Subjects Reporting Solicited Local and General Symptoms

Timepoint [43]

Within the 4 days (Day 0-3) post-vaccination period following the fourth dose

Secondary outcome [44]

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Timepoint [44]

Within 31 days (Day 0-30) following the primary vaccination course

Secondary outcome [45]

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Timepoint [45]

Within 31 days (Day 0-30) following the fourth dose

Secondary outcome [46]

Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)

Timepoint [46]

Within 4 days (Day 0 to Day 3) after fourth dose vaccination

Secondary outcome [47]

Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination

Timepoint [47]

Within 43 days (Day 0 through Day 42) after vaccination

Secondary outcome [48]

Number of Subjects Reporting Serious Adverse Events (SAEs)

Timepoint [48]

From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose

Secondary outcome [49]

Number of Subjects Reporting Serious Adverse Events (SAEs)

Timepoint [49]

From the fourth dose through the end of the 6-month safety follow-up

Secondary outcome [50]

Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)

Timepoint [50]

From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

Secondary outcome [51]

Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)

Timepoint [51]

From the fourth dose through the end of the 6-month safety follow-up

Secondary outcome [52]

Number of Subjects Reporting Rash

Timepoint [52]

From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

Secondary outcome [53]

Number of Subjects Reporting Rash

Timepoint [53]

From the fourth dose through the end of the 6-month safety follow-up

Secondary outcome [54]

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Timepoint [54]

From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

Secondary outcome [55]

Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.

Timepoint [55]

From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

Secondary outcome [56]

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Timepoint [56]

From the fourth dose through the end of the 6-month safety follow-up

Secondary outcome [57]

Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits

Timepoint [57]

From the fourth dose through the end of the 6-month safety follow-up

Secondary outcome [58]

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).

Timepoint [58]

Prior to the fourth dose vaccination

Secondary outcome [59]

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.

Timepoint [59]

Prior to the fourth dose vaccination

Eligibility

Key inclusion criteria

* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol
* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after 36 weeks gestation.
* Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
* Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Minimum age

6 Weeks

Maximum age

15 Months

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

* History of measles, mumps, rubella or varicella.
* Previous vaccination against measles, mumps, rubella or varicella.
* Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
* Patients receiving immunosuppressive therapy.
* Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
* Individuals with primary and acquired immunodeficiency states.
* Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* Individuals with active tuberculosis.
* Acute disease at time of booster vaccination.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

22/02/2006

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

26/02/2008

Sample size

Target

Accrual to date

Final

4441

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

GSK Investigational Site - Randwick

Recruitment hospital [2]

GSK Investigational Site - Herston

Recruitment hospital [3]

GSK Investigational Site - South Brisbane

Recruitment hospital [4]

GSK Investigational Site - Carlton

Recruitment postcode(s) [1]

2031 - Randwick

Recruitment postcode(s) [2]

4029 - Herston

Recruitment postcode(s) [3]

4101 - South Brisbane

Recruitment postcode(s) [4]

3053 - Carlton

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Alabama

Country [2]

United States of America

State/province [2]

Arizona

Country [3]

United States of America

State/province [3]

Arkansas

Country [4]

United States of America

State/province [4]

California

Country [5]

United States of America

State/province [5]

Colorado

Country [6]

United States of America

State/province [6]

Connecticut

Country [7]

United States of America

State/province [7]

Florida

Country [8]

United States of America

State/province [8]

Idaho

Country [9]

United States of America

State/province [9]

Iowa

Country [10]

United States of America

State/province [10]

Kansas

Country [11]

United States of America

State/province [11]

Kentucky

Country [12]

United States of America

State/province [12]

Louisiana

Country [13]

United States of America

State/province [13]

Maryland

Country [14]

United States of America

State/province [14]

Massachusetts

Country [15]

United States of America

State/province [15]

Michigan

Country [16]

United States of America

State/province [16]

Minnesota

Country [17]

United States of America

State/province [17]

Nebraska

Country [18]

United States of America

State/province [18]

Nevada

Country [19]

United States of America

State/province [19]

New York

Country [20]

United States of America

State/province [20]

North Carolina

Country [21]

United States of America

State/province [21]

Ohio

Country [22]

United States of America

State/province [22]

Oklahoma

Country [23]

United States of America

State/province [23]

Oregon

Country [24]

United States of America

State/province [24]

Pennsylvania

Country [25]

United States of America

State/province [25]

Rhode Island

Country [26]

United States of America

State/province [26]

South Carolina

Country [27]

United States of America

State/province [27]

Texas

Country [28]

United States of America

State/province [28]

Utah

Country [29]

United States of America

State/province [29]

Virginia

Country [30]

United States of America

State/province [30]

Washington

Country [31]

United States of America

State/province [31]

Wisconsin

Country [32]

Mexico

State/province [32]

Mexico, D.F.

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

GlaxoSmithKline

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

Trial website

https://clinicaltrials.gov/study/NCT00289783

Trial related presentations / publications

Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
Bryant KA, Marshall GS, Marchant CD, Pavia-Ruiz N, Nolan T, Rinderknecht S, Blatter M, Aris E, Lestrate P, Boutriau D, Friedland LR, Miller JM. Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics. 2011 Jun;127(6):e1375-85. doi: 10.1542/peds.2009-2992. Epub 2011 May 29.
Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.
Bryant KA et al. Immune response to measles, mumps, rubella (MMR) and varicella (V) vaccine coadministered with a fourth dose of Haemophilus influenzae type b - Neisseria meningitidis serogroups C and Y - tetanus toxoid conjugate (HibMenCY) vaccine in toddlers. Abstract presented at the Annual meeting of Pediatric Academic Societies (PAS). Vancouver, Canada, 1-4 May 2010.
Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.

Public notes

Contacts

Principal investigator

Name

GSK Clinical Trials

Address

GlaxoSmithKline

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00289783

Trial Review

Did you know?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00289783