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OpenTrials
Completed

NCT Number: NCT01340937

A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.

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Key information

Conditions

Bacterial Infections Actinomycetales Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Picornaviridae Infections Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

46 day–89 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This study is partially Double-Blinded in that the participants' parents/guardians, investigator/study site personnel, and Sponsor's representatives will be blinded to the lot of V419 the participant is randomized to receive, but not to the participant's treatment group (V419 or control).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant is a healthy infant
  • Participant has received one dose of monovalent hepatitis B vaccine prior to 1 month of age

Exclusion criteria

  • Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
  • Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines or any combination of the above
  • Participant has had an illness with fever within 24 hours of study enrollment
  • Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or live virus vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 15 days or more prior to enrollment
  • Participant or his/her mother has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)
  • Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection

Treatment and study plan

V419

Biological

V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.

PENTACEL™

Biological

PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group

Prevnar 13™

Biological

Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age

RotaTeq™

Biological

RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

Recombivax HB vaccine

Biological

Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age

Primary outcomes

  1. Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.

  2. Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).

  3. Geometric Mean Concentration of Antibodies to Diphtheria Toxin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).

  4. Geometric Mean Concentration of Antibodies to Tetanus Toxin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.

  5. Geometric Mean Concentration of Antibodies to Pertussis Toxin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).

  6. Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.

  7. Geometric Mean Concentration of Antibodies to Pertussis Pertactin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.

  8. Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.

  9. Geometric Mean Titer for Antibodies to Poliovirus Type 1

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).

  10. Geometric Mean Titer for Antibodies to Poliovirus Type 2

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.

  11. Geometric Mean Titer for Antibodies to Poliovirus Type 3

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.

Secondary outcomes

  1. Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer >=0.15 µg/mL and >=1.0 µg/mL.

  2. Percentage of Participants Responding to Hepatitis B Surface Antigen

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 mIU/mL.

  3. Percentage of Participants Responding to Diphtheria Toxin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 IU/mL.

  4. Percentage of Participants Responding to Tetanus Toxin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.

  5. Percentage of Participants Responding to Pertussis Toxin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.

  6. Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.

  7. Percentage of Participants Responding to Pertussis Pertactin

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.

  8. Percentage of Participants Responding to Pertussis Fimbriae

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.

  9. Percentage of Participants Responding to Poliovirus Type 1

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.

  10. Percentage of Participants Responding to Poliovirus Type 2

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.

  11. Percentage of Participants Responding to Poliovirus Type 3

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.

  12. Geometric Mean Concentration of Antibodies to Pertussis Toxin

    Time frame: Postdose 4 (Month 16)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  13. Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin

    Time frame: Postdose 4 (Month 16)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  14. Geometric Mean Concentration of Antibodies to Pertussis Pertactin

    Time frame: Postdose 4 (Month 16)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  15. Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

    Time frame: Postdose 4 (Month 16)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  16. Percentage of Participants Responding to Pertussis Toxin

    Time frame: Postdose 4 (Month 16)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  17. Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin

    Time frame: Postdose 4 (Month 16)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  18. Percentage of Participants Responding to Pertussis Pertactin

    Time frame: Postdose 4 (Month 16)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  19. Percentage of Participants Responding to Pertussis Fimbriae

    Time frame: Postdose 4 (Month 16)

    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  20. Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes

    Time frame: Postdose 3 (Month 7)

    Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

  21. Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions

    Time frame: Up to 5 days after any infant vaccination (up to 6 months)

    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.

  22. Percentage of Participants With Elevated Temperature by Severity

    Time frame: Up to 5 days after any infant vaccination (up to 6 months)

    Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • MCM Vaccines B.V.

Registry information

Official study title

A Phase III Randomized, Partially Double-Blind, Active-Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq ™

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 25, 2011
Registry last updated
Nov 15, 2018

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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