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Completed

NCT Number: NCT00551915

A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 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 3 formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.

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Key information

Conditions

Bacterial Infections; Virus Diseases Bacterial Infections Bacterial Infections and Mycoses Infections Virus Diseases

Age range

6 week–9 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Participants will be randomized into 4 arms:

AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (PRP) conjugated 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 polyribosylribitol phosphate 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

PENTACEL™ + RECOMBIVAX HB™: open-label control group receiving PENTACEL™ (licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b) and RECOMBIVAX HB™ (licensed vaccine for hepatitis)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • HIV infection in participant (child/mother)
  • Documented HBsAg seropositivity in the participant (child or mother)
  • History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
  • History of seizure 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
  • Known hypersensitivity to any component of the investigational or marketed vaccines being administered in this protocol
  • Any history or condition that would exclude the participant from receiving any vaccine administered under this protocol based on the contraindications that appear in the package circulars for each component of these vaccines
  • Any condition that, in the opinion of the investigator, is not stable or may interfere with the evaluation of the study objectives

Treatment and study plan

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

PENTACEL™

Biological

licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label

RECOMBIVAX HB™

Biological

licensed vaccine for hepatitis, administered open-label

Primary outcomes

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

    Time frame: At 7 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

    Time frame: At 7 months of age (1 month after 3rd vaccination)

  3. Percentage of participants with a ≥4-fold rise in levels of antibodies to pertussis antigens at the Postdose 3 time point

    Time frame: At 7 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

    Time frame: At 7 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

    Time frame: At 7 months of age (1 month after 3rd vaccination)

  6. Percentage of participants with neutralizing anti-poliovirus type antibodies at ≥1:8 dilution at the Postdose 3 time point

    Time frame: At 7 months of age (1 month after 3rd vaccination)

Secondary outcomes

  1. Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 2 time point

    Time frame: At 6 months of age (2 months after 2nd vaccination)

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

    Time frame: At 6 months of age (2 months after 2nd vaccination)

  3. Percentage of participants with a ≥4-fold rise in level of antibodies to pertussis antigens at the Postdose 2 time point

    Time frame: At 6 months of age (2 months after 2nd vaccination)

  4. Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 2 time point

    Time frame: At 6 months of age (2 months after 2nd vaccination)

  5. Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 2 time point

    Time frame: At 6 months of age (2 months after 2nd vaccination)

  6. Percentage of participants with neutralizing anti-poliovirus type antibodies at ≥1:8 dilution at the Postdose 2 time point

    Time frame: At 6 months of age (2 months after 2nd vaccination)

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

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

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

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Safety, Tolerability, and Immunogenicity of 3 Different Formulations of a Liquid Hexavalent Combination Vaccine, HR5I When Administered to Healthy Hepatitis B Vaccine-Naive Infants at 2, 4, 6, and 12-14 Months of Age

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Oct 31, 2007
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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