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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01340937
Recruitment Status : Completed
First Posted : April 25, 2011
Results First Posted : May 2, 2016
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
MCM Vaccines B.V.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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™.

Condition or disease Intervention/treatment Phase
Bacterial Infections Virus Diseases Biological: V419 Biological: PENTACEL™ Biological: Prevnar 13™ Biological: RotaTeq™ Biological: Recombivax HB vaccine Phase 3

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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 ™
Actual Study Start Date : May 10, 2011
Actual Primary Completion Date : December 18, 2012
Actual Study Completion Date : July 26, 2013


Arm Intervention/treatment
Experimental: V419 Lot A
V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
Biological: V419
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.

Biological: PENTACEL™
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

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

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

Experimental: V419 Lot B
V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
Biological: V419
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.

Biological: PENTACEL™
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

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

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

Experimental: V419 Lot C
V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
Biological: V419
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.

Biological: PENTACEL™
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

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

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

Active Comparator: Control
Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age
Biological: PENTACEL™
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

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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   46 Days to 89 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340937


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
MCM Vaccines B.V.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01340937     History of Changes
Other Study ID Numbers: V419-006
First Posted: April 25, 2011    Key Record Dates
Results First Posted: May 2, 2016
Last Update Posted: November 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Keywords provided by Merck Sharp & Dohme Corp.:
Diphtheria
Tetanus
Whooping Cough (pertussis)
Poliomyelitis
Hepatitis B infection
Haemophilus influenzae type b infection

Additional relevant MeSH terms:
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Infection
Bacterial Infections
Virus Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs