NCT01839188

Brief Summary

To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age Primary objectives

  • To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule
  • To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule Secondary objectives
  • To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
  • To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine
  • To describe the safety profile after each dose of study vaccines administered

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2013

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2014

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

February 25, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

April 19, 2013

Results QC Date

January 28, 2019

Last Update Submit

February 21, 2019

Conditions

Neisseria MeningitidisBacterial InfectionsVirus Diseases

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL

    The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.

    Month 5 (one month after receiving Vaccination 3)

  • Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL

    The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.

    Month 5 (one month after receiving Vaccination 3)

Secondary Outcomes (17)

  • Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)

    Month 5 (one month after receiving Vaccination 3)

  • Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen

    Month 5 (one month after receiving Vaccination 3)

  • Geometric Mean Concentration of Antibodies to Diphtheria Toxin

    Month 5 (one month after receiving Vaccination 3)

  • Geometric Mean Concentration of Antibodies to Tetanus Toxin

    Month 5 (one month after receiving Vaccination 3)

  • Geometric Mean Concentrations of Antibodies to Pertussis Antigens

    Month 5 (one month after receiving Vaccination 3)

  • +12 more secondary outcomes

Study Arms (1)

PR5I (V1); Pediacel® (V2); PR5I (V3)

EXPERIMENTAL

\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.

Biological: PR5IBiological: Pediacel®Biological: NeisVac-C®Biological: RotaTeq®Biological: Prevenar 13®

Interventions

PR5IBIOLOGICAL

Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Hepatitis B \[HB; Recombinant DNA\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age.

Also known as: V419, Vaxelis®, DTaP-HB-IPV-Hib
PR5I (V1); Pediacel® (V2); PR5I (V3)
Pediacel®BIOLOGICAL

Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age.

Also known as: DTaP-IPV-Hib
PR5I (V1); Pediacel® (V2); PR5I (V3)
NeisVac-C®BIOLOGICAL

Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.

PR5I (V1); Pediacel® (V2); PR5I (V3)
RotaTeq®BIOLOGICAL

Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying.

PR5I (V1); Pediacel® (V2); PR5I (V3)
Prevenar 13®BIOLOGICAL

Pneumococcal polysaccharide conjugate vaccine \[PCV; 13-valent, adsorbed\]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.

Also known as: PCV-13
PR5I (V1); Pediacel® (V2); PR5I (V3)

Eligibility Criteria

Age46 Days - 76 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infant 46 to 74 days (both inclusive)
  • Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
  • Parent(s)/legal representative able to comply with the study procedures

You may not qualify if:

  • Participation in any study with an investigational compound or device since birth
  • History of congenital or acquired immunodeficiency
  • Chronic illness that could interfere with study conduct or completion
  • Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
  • Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
  • History or maternal history of HBsAg seropositivity
  • Coagulation disorder that contraindicate intramuscular injection
  • History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
  • History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
  • Receipt of immune globulin, blood or blood-derived products since birth
  • Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Martinon-Torres F, Boisnard F, Thomas S, Sadorge C, Borrow R; PRI02C study group. Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib). Vaccine. 2017 Jun 27;35(30):3764-3772. doi: 10.1016/j.vaccine.2017.05.043. Epub 2017 Jun 2.

    PMID: 28583305DERIVED

MeSH Terms

Conditions

Bacterial InfectionsVirus Diseases

Interventions

Vaxelisdiphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccineRotaTeq13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2013

First Posted

April 24, 2013

Study Start

May 1, 2013

Primary Completion

March 19, 2014

Study Completion

March 19, 2014

Last Updated

February 25, 2019

Results First Posted

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information