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AzTrials

Hepatitis A VirusPhase 4NCT00289913

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)

A Phase 4 study testing Comparator: VAQTA™, Comparator: Infanrix™ and Comparator: PedvaxHIB™ in people with Hepatitis A Virus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 12 to 17 monthsHealthy volunteers can take part
Conditions the study is for
Hepatitis A Virus
What is being tested?
Comparator: VAQTA™, Comparator: Infanrix™ and Comparator: PedvaxHIB™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,274 participants
Where
No sites listed yet
Study dates
Apr 2006to Jun 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
Comparator: VAQTA™, Comparator: Infanrix™, Comparator: PedvaxHIB™
Keywords
Hepatitis A virus
Medical subject headings
Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comparator: VAQTA™Biological

    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.

  • Comparator: Infanrix™Biological

    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.

  • Comparator: PedvaxHIB™Biological

    Also called 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.

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

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

Study groups in NCT00289913
Study groupRoleWhat they receive
VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1)ExperimentalDay 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.
Receives: Biological: Comparator: VAQTA™; Biological: Comparator: Infanrix™; Biological: Comparator: PedvaxHIB™
PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1)ExperimentalDay 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.
Receives: Biological: Comparator: VAQTA™; Biological: Comparator: Infanrix™; Biological: Comparator: PedvaxHIB™
VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1)ExperimentalDay 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.
Receives: Biological: Comparator: VAQTA™; Biological: Comparator: PedvaxHIB™
PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1)ExperimentalDay 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
Receives: Biological: Comparator: VAQTA™; Biological: Comparator: PedvaxHIB™
VAQTA™/VAQTA™ (Stage 2)ExperimentalDay 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered.
Receives: Biological: Comparator: VAQTA™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seropositivity Rate (SPR) to Hepatitis A

    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).

    Measured: 4 weeks after dose 2 of VAQTA™

  2. Antibody Response Rate to Haemophilus Influenzae Type b (Hib)

    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™.

    Measured: 4 weeks postvaccination with PedvaxHIB™

  3. Number of Participants With Adverse Events (AE)

    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.

    Measured: 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

  4. Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™

    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.

    Measured: 4 weeks postvaccination with Infanrix™

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00289913
Sponsor's protocol ID
V251-068
Other IDs
2005_076
Status last verified
Mar 2017
First submitted
8 Feb 2006
Last updated
13 Apr 2017
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Petrecz M, Ramsey KP, Stek JE, Martin JC, Klopfer SO, Kuter B, Schodel FP, Lee AW. Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children. Hum Vaccin Immunother. 2016;12(2):503-11. doi: 10.1080/21645515.2015.1080395.

    PubMed 26308112

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Comparator: VAQTA™, Comparator: Infanrix™ and Comparator: PedvaxHIB™ in people with Hepatitis A Virus, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seropositivity Rate (SPR) to Hepatitis A (time frame: 4 weeks after dose 2 of VAQTA™). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.

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