Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00289913
First received: February 8, 2006
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the administration of VAQTA™ in healthy children 15 months of age at study entry.


Condition Intervention Phase
Hepatitis A Virus
Biological: Comparator: VAQTA™
Biological: Comparator: Infanrix™
Biological: Comparator: PedvaxHIB™
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of VAQTA™ Given Concomitantly With PedvaxHIB™ and Infanrix™ in Healthy Children 15 Months of Age

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Seropositivity Rate (SPR) to Hepatitis A [ Time Frame: 4 weeks after dose 2 of VAQTA™ ] [ Designated as safety issue: No ]
    SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).

  • Antibody Response Rate to Haemophilus Influenzae Type b (Hib) [ Time Frame: 4 weeks postvaccination with PedvaxHIB™ ] [ Designated as safety issue: No ]

    Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL.

    The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™.


  • Number of Participants With Adverse Events (AE) [ Time Frame: Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs ] [ Designated as safety issue: Yes ]

    Systemic and injection site AEs were collected from participants receiving

    • VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
    • VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
    • VAQTA™ administered alone (Stage II)

    Safety data was collected on a standardized Vaccination Report Card (VRC)

    following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE.


  • Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ [ Time Frame: 4 weeks postvaccination with Infanrix™ ] [ Designated as safety issue: No ]

    GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™.

    IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL.

    IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL.

    IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL.



Enrollment: 1274
Study Start Date: April 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1)

Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.

Week 24: The second dose of VAQTA™ was administered.

Biological: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Biological: Comparator: Infanrix™

Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis

Vaccine Adsorbed, GlaxoSmithKline).

One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.

Biological: Comparator: PedvaxHIB™

PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).

One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Other Names:
  • One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study
  • visit in all treatment groups in the study.
Experimental: PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1)

Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.

Week 4: The first dose of VAQTA™ was administered.

Week 28: The second dose of VAQTA™ was administered.

Biological: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Biological: Comparator: Infanrix™

Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis

Vaccine Adsorbed, GlaxoSmithKline).

One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.

Biological: Comparator: PedvaxHIB™

PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).

One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Other Names:
  • One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study
  • visit in all treatment groups in the study.
Experimental: VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1)

Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.

Week 24: The second dose of VAQTA™ was administered.

Biological: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Biological: Comparator: PedvaxHIB™

PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).

One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Other Names:
  • One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study
  • visit in all treatment groups in the study.
Experimental: PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1)

Day 1: PedvaxHIB™ was administered.

Week 4: The first dose of VAQTA™ was administered.

Week 28: The second dose of VAQTA™ was administered.

Biological: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Biological: Comparator: PedvaxHIB™

PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).

One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Other Names:
  • One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study
  • visit in all treatment groups in the study.
Experimental: VAQTA™/VAQTA™ (Stage 2)

Day 1: The first dose of VAQTA™ was administered.

Week 24: The second dose of VAQTA™ was administered.

Biological: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.


Detailed Description:

In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated.

In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart. Safety data was collected after each dose.

  Eligibility

Ages Eligible for Study:   12 Months to 17 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stage 1) Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases
  • Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A

Exclusion Criteria:

  • Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, a history of seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder
  • Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289913

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00289913     History of Changes
Other Study ID Numbers: V251-068, 2005_076
Study First Received: February 8, 2006
Results First Received: June 9, 2011
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatitis A virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on April 14, 2014