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Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Primary Purpose

Hepatitis A

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Havrix™
Infanrix™
ActHIB™
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A

Eligibility Criteria

12 Months - 13 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol A male or female child 12 or 13 months of age at the time of entry into the Enrolment Phase, Subjects must have previously received three doses each of DTaP and Hib vaccines during the first year of life. The three doses of DTaP vaccine must have been administered as either Infanrix™ or Pediarix™ and the three doses of Hib vaccine must have been administered as ActHIB™, HibTITER™, OmniHIB™. Subjects who, at 15 months of age, will have had at least six months elapse since their third dose of Infanrix™ or Pediarix™, Written informed consent obtained from the parents or guardian of the subject, Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and Parents/guardian of the subject must have a telephone or be able to be contacted by telephone. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 31 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. Planned administration or administration of any vaccine not foreseen by the study protocol during the period 42 days before and 31 days after each dose of study vaccine(s). Previous vaccination against DTaP using a commercially-available brand other than Infanrix™ or Pediarix™ or against Hib using a commercially-available brand other than ActHIB™, HibTITER™ or OmniHIB™. Previous vaccination with more than three doses of DTaP-containing vaccines or more than three doses of Hib-containing vaccines. Previous vaccination against hepatitis A, History or known exposure to hepatitis A, History of diphtheria, tetanus, pertussis and/or Haemophilus influenza type b, Known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenza type b within 31 days prior to the start of the study, History of non-response to any vaccine in the current routine immunization schedule, Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection, History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix™, Infanrix™ or ActHIB™ including 2-phenoxyethanol, neomycin and gelatin, History of hypersensitivity/allergic reaction to latex Major congenital defects or serious chronic illness, History of any neurologic disorder Acute disease at the time of vaccination. Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period, i.e., the Enrolment Phase, the Active Phase and the Extended Safety Follow-up Phase

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Havrix Group

Infanrix + ActHIB→Havrix Group

Havrix + Infanrix + ActHIB Group

Arm Description

Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.

Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.

Outcomes

Primary Outcome Measures

Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects
Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)
Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.

Secondary Outcome Measures

Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)
GMCs are expressed as International Units per milliliter (IU/mL).
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)
GMCs are expressed as microgram/milliliter (µg/mL).
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)
Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix
Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix
Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
Number of Subjects With Vaccine Response to Havrix™.
Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.
Number of Subjects Reporting Solicited Local Adverse Events (AEs)
Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.
Number of Subjects Reporting Solicited General Adverse Events (AEs)
Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events
Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.

Full Information

First Posted
September 15, 2005
Last Updated
July 2, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00197236
Brief Title
Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
Official Title
Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 Months of Age
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 11, 2003 (undefined)
Primary Completion Date
December 3, 2007 (Actual)
Study Completion Date
December 3, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
An open, controlled comparison of Havrix™ administered alone or with Infanrix™ and ActHIB. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3) Infanrix™ and ActHIB followed by Havrix™ one month later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A
Keywords
Hepatitis A

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Havrix Group
Arm Type
Active Comparator
Arm Description
Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
Arm Title
Infanrix + ActHIB→Havrix Group
Arm Type
Experimental
Arm Description
Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Arm Title
Havrix + Infanrix + ActHIB Group
Arm Type
Active Comparator
Arm Description
Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
Intervention Type
Biological
Intervention Name(s)
Havrix™
Intervention Description
2 intramuscular injections, 6 months apart
Intervention Type
Biological
Intervention Name(s)
Infanrix™
Intervention Description
1 intramuscular injection
Intervention Type
Biological
Intervention Name(s)
ActHIB™
Intervention Description
1 intramuscular injection
Primary Outcome Measure Information:
Title
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix
Description
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Time Frame
31 days following the second dose of Havrix™
Title
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects
Description
Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.
Time Frame
31 days following the administration of Infanrix™ and ActHIB
Title
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)
Description
Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.
Time Frame
31 days following the administration of Infanrix™ and ActHIB
Secondary Outcome Measure Information:
Title
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)
Description
GMCs are expressed as International Units per milliliter (IU/mL).
Time Frame
31 days following the administration of Infanrix™ and ActHIB
Title
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)
Description
GMCs are expressed as microgram/milliliter (µg/mL).
Time Frame
31 days following the administration of Infanrix™ and ActHIB
Title
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)
Description
Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.
Time Frame
31 days following the administration of Infanrix™ and ActHIB
Title
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix
Description
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Time Frame
31 days following the first dose of Havrix™
Title
Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix
Description
Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
Time Frame
31 days following the first dose of Havrix™
Title
Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix
Description
Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
Time Frame
31 days following the second dose of Havrix™
Title
Number of Subjects With Vaccine Response to Havrix™.
Description
Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.
Time Frame
31 days following the second dose
Title
Number of Subjects Reporting Solicited Local Adverse Events (AEs)
Description
Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.
Time Frame
4-day period following each dose of study vaccine(s)
Title
Number of Subjects Reporting Solicited General Adverse Events (AEs)
Description
Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.
Time Frame
4-day period following each dose of study vaccine(s)
Title
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
31-day period following each dose of study vaccine(s)
Title
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events
Description
Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.
Time Frame
Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
13 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol A male or female child 12 or 13 months of age at the time of entry into the Enrolment Phase, Subjects must have previously received three doses each of DTaP and Hib vaccines during the first year of life. The three doses of DTaP vaccine must have been administered as either Infanrix™ or Pediarix™ and the three doses of Hib vaccine must have been administered as ActHIB™, HibTITER™, OmniHIB™. Subjects who, at 15 months of age, will have had at least six months elapse since their third dose of Infanrix™ or Pediarix™, Written informed consent obtained from the parents or guardian of the subject, Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and Parents/guardian of the subject must have a telephone or be able to be contacted by telephone. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 31 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. Planned administration or administration of any vaccine not foreseen by the study protocol during the period 42 days before and 31 days after each dose of study vaccine(s). Previous vaccination against DTaP using a commercially-available brand other than Infanrix™ or Pediarix™ or against Hib using a commercially-available brand other than ActHIB™, HibTITER™ or OmniHIB™. Previous vaccination with more than three doses of DTaP-containing vaccines or more than three doses of Hib-containing vaccines. Previous vaccination against hepatitis A, History or known exposure to hepatitis A, History of diphtheria, tetanus, pertussis and/or Haemophilus influenza type b, Known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenza type b within 31 days prior to the start of the study, History of non-response to any vaccine in the current routine immunization schedule, Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection, History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix™, Infanrix™ or ActHIB™ including 2-phenoxyethanol, neomycin and gelatin, History of hypersensitivity/allergic reaction to latex Major congenital defects or serious chronic illness, History of any neurologic disorder Acute disease at the time of vaccination. Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period, i.e., the Enrolment Phase, the Active Phase and the Extended Safety Follow-up Phase
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
GSK Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
GSK Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
GSK Investigational Site
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19810
Country
United States
Facility Name
GSK Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
GSK Investigational Site
City
Martinez
State/Province
Georgia
ZIP/Postal Code
30907
Country
United States
Facility Name
GSK Investigational Site
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
GSK Investigational Site
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
GSK Investigational Site
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
GSK Investigational Site
City
Ithaca
State/Province
New York
ZIP/Postal Code
14850
Country
United States
Facility Name
GSK Investigational Site
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
GSK Investigational Site
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
GSK Investigational Site
City
Bellevue
State/Province
Pennsylvania
ZIP/Postal Code
15202
Country
United States
Facility Name
GSK Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
GSK Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
GSK Investigational Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24549
Country
United States
Facility Name
GSK Investigational Site
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23111
Country
United States
Facility Name
GSK Investigational Site
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
21494175
Citation
Trofa AF, Klein NP, Paul IM, Michaels MG, Goessler M, Chandrasekaran V, Blatter M. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with Diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines in children 15 months of age. Pediatr Infect Dis J. 2011 Sep;30(9):e164-9. doi: 10.1097/INF.0b013e31821b8a7d.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208109/232
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208109/232
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208109/232
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208109/232
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208109/232
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208109/232
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

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