AzTrials
AzTrials

Bacterial Infections; Virus DiseasesPhase 2NCT00551629

A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)

A Phase 2 study testing AR51 (12, 10), PR51 (3, 10) and PR51 (6, 10) in people with Bacterial Infections; Virus Diseases, 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
Search all trials

Trial summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4 different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). Read more about this study

Who is it for?
Ages 6 to 9 weeksHealthy volunteers can take part
Conditions the study is for
Bacterial Infections; Virus Diseases
What is being tested?
AR51 (12, 10), PR51 (3, 10) and PR51 (6, 10)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
708 participants
Where
No sites listed yet
Study dates
May 2001to Mar 2003
Phase
Phase 2
Are there results?
None posted in the registry

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 6 to 9 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria/Pertussis/Tetanus (DPT), or Polio

Who cannot join

  • Documented HIV infection (child or mother)
  • Documented HBsAg-seropositivity (child or mother)
  • History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
  • History of seizure disorder, developmental delay, or any other neurologic disorder
  • Underlying medical conditions such as inborn errors of metabolism, failure to thrive, or any major congenital abnormalities requiring surgery
  • Prior or anticipated receipt of immune globulin, blood, or blood products
Show all 9Show fewer
  • Known hypersensitivity to any component of the investigational vaccines being administered in this protocol
  • Any history or condition that would exclude the child from receiving any vaccine administered under this protocol
  • Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives

About this study

Official title: Safety, Tolerability, and Immunogenicity of Four Different Formulations of a Liquid Hexavalent Combination Vaccine, HR5I (Haemophilus Influenzae Type b Conjugate, Recombinant Hepatitis B Surface Antigen, Diphtheria Toxoid, Tetanus Toxoid, 5-Component Acellular Pertussis Vaccine, and Inactivated Poliovirus Type 1, 2, and 3), When Administered to Healthy Hepatitis B Vaccine-Naïve Infants at 2, 3, 4, and 12 to 14 Months of Age

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4 different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 4 formulations of HR5I administered as a primary series at 2, 3, and 4 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.

Read the detailed description

Participants will be randomized into 4 arms:

AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (PRP) conjugates to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface antigen (HBsAg)

PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of PRP conjugated to the outer membrane protein complex of Neisseria meningitides (PRP-OMPC) and 10 mcg of HBsAg

PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg

PR51 (6, 15): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg

Being tested
AR51 (12, 10), PR51 (3, 10), PR51 (6, 10), PR51 (6, 15)
Medical subject headings
Bacterial Infections, Virus Diseases

What participants receive

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

  • AR51 (12, 10)Biological

    vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg

  • PR51 (3, 10)Biological

    vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg

  • PR51 (6, 10)Biological

    vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg

  • PR51 (6, 15)Biological

    vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg

Study groups in NCT00551629
Study groupRoleWhat they receive
AR51 (12, 10)ExperimentalParticipants were vaccinated with 0.5 ml of AR51 (12, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.
Receives: Biological: AR51 (12, 10)
PR51 (3, 10)ExperimentalParticipants were vaccinated with 0.5 ml of PR51 (3, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.
Receives: Biological: PR51 (3, 10)
PR51 (6, 10)ExperimentalParticipants were vaccinated with 0.5 ml of PR51 (6, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.
Receives: Biological: PR51 (6, 10)
PR51 (6, 15)ExperimentalParticipants were vaccinated with 0.5 ml of PR51 (6, 15) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.
Receives: Biological: PR51 (6, 15)

What is being measured

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

  1. Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point

    Measured: At 5 months of age (1 month after 3rd vaccination)

  2. Percentage of participants with level of anti-HBsAg antibodies ≥10 mIU/L at the Postdose 3 time point

    Measured: At 5 months of age (1 month after 3rd vaccination)

  3. Percentage of participants with a ≥4-fold rise in levels of antibodies to pertussis antigens (toxoid [PTxd], Filamentous Hemagglutinin [FHA], Fimbria 2 & Fimbria 3 [FIM], and Pertactin [PRN]) at the Postdose 3 time point

    Measured: At 5 months of age (1 month after 3rd vaccination)

  4. Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 3 time point

    Measured: At 5 months of age (1 month after 3rd vaccination)

  5. Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 3 time point

    Measured: At 5 months of age (1 month after 3rd vaccination)

  6. Percentage of participants with neutralizing anti-poliovirus antibodies (Types 1, 2, and 3) at ≥1:8 dilution at the Postdose 3 time point

    Measured: At 5 months of age (1 month after 3rd vaccination)

Secondary outcomes (2)

  1. Number of participants with at least 1 adverse event (AE)

    Measured: From 1st vaccination up to 14 days following last vaccination (up to 14.5 months)

  2. Number of participants who discontinued study treatment due to an AE

    Measured: From 1st vaccination up to 14 days following last vaccination (up to 14.5 months)

Timeline

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

  1. First posted31 Oct 2007 (estimated)
  2. Study startMay 2001
  3. Primary completionMar 2003
  4. Study completionMar 2003

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00551629
Sponsor's protocol ID
V419-002
Other IDs
2007_580
Status last verified
Oct 2015
First submitted
29 Oct 2007
Last updated
30 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Halperin SA, Tapiero B, Diaz-Mitoma F, Law BJ, Hoffenbach A, Zappacosta PS, Radley D, McCarson BJ, Martin JC, Brackett LE, Boslego JW, Hesley TM, Bhuyan PK, Silber JL. Safety and immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 3, 4, and 12-14 months of age. Vaccine. 2009 Apr 28;27(19):2540-7. doi: 10.1016/j.vaccine.2008.11.115. Epub 2009 Jan 3.

    PubMed 19124057

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AR51 (12, 10), PR51 (3, 10) and PR51 (6, 10) in people with Bacterial Infections; Virus Diseases, 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 1 inclusion and 9 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 30 Oct 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point (time frame: At 5 months of age (1 month after 3rd vaccination)). The study lists 6 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 NCT00551629, 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 30 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in