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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014