NCT01392378

Brief Summary

The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
908

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

14 active sites

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

July 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 26, 2014

Completed
Last Updated

February 26, 2014

Status Verified

January 1, 2014

Enrollment Period

1.4 years

First QC Date

July 8, 2011

Results QC Date

January 10, 2014

Last Update Submit

January 10, 2014

Conditions

Pneumococcal Vaccines

Keywords

Prevenar 1313vPnCAntipyretic medicationHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series

    Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.

    1 month after the infant series

Secondary Outcomes (23)

  • Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series

    1 month after the infant series

  • Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

    1 month after the toddler dose

  • Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series

    1 month after the infant series

  • Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series

    1 month after the infant series

  • Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series

    1 month after the infant series

  • +18 more secondary outcomes

Study Arms (5)

Group 1

EXPERIMENTAL

Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.

Biological: 13-valent pneumococcal conjugate vaccineBiological: INFANRIX hexaDrug: Paracetamol

Group 2

EXPERIMENTAL

Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.

Biological: 13-valent pneumococcal conjugate vaccineBiological: INFANRIX hexaDrug: Ibuprofen

Group 3

EXPERIMENTAL

Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.

Biological: 13-valent pneumococcal conjugate vaccineBiological: INFANRIX hexaDrug: Paracetamol

Group 4

EXPERIMENTAL

Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.

Biological: 13-valent pneumococcal conjugate vaccineBiological: INFANRIX hexaDrug: Ibuprofen

Group 5

EXPERIMENTAL

Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. This group does not receive any antipyretic medication as part of the study.

Biological: 13-valent pneumococcal conjugate vaccineBiological: INFANRIX hexa

Interventions

13-valent pneumococcal conjugate vaccineBIOLOGICAL

13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

Group 1
INFANRIX hexaBIOLOGICAL

INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

Group 1
ParacetamolDRUG

Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.

Group 1
IbuprofenDRUG

Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.

Group 2

Eligibility Criteria

Age56 Days - 98 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 2 months (56 to 98 days) at time of enrollment.
  • Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

You may not qualify if:

  • Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Allergy or contraindication to paracetamol or ibuprofen administration.
  • Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Gabinet Lekarski

Dębica, 39-200, Poland

Location

Hanna Czajka Indywidualna Praktyka Lekarska

Krakow, 31-302, Poland

Location

NZOZ "Praktimed" sp. z o.o.

Krakow, 31-422, Poland

Location

Specjalistyczna Praktyka Lekarska Gravita

Lodz, 91-347, Poland

Location

SP ZOZ Lubartow

Lubartów, 21-100, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego Eskulap

Lublin, 20-044, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak

Oborniki Śląskie, 55-120, Poland

Location

Specjalistyczny ZOZ nad Matka i Dzieckiem, Oddzial Obserwacyjno Zakazny A, Szpital Dzieciecy

Poznan, 61-734, Poland

Location

NZLA Michalkowice Jarosz i Partnerzy

Siemianowice Śląskie, 41-103, Poland

Location

NZOZ Nasz Lekarz

Torun, 87-100, Poland

Location

Szpital im. Sw. Jadwigi Slaskiej, Oddzia Pediatryczny

Trzebnica, 55-100, Poland

Location

DEN-MED Gabinet Lekarsko-Stomatologiczny Joanna i Jacek Witwiccy

Warsaw, 02-127, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

Wroclaw, 50-345, Poland

Location

NZOZ Salmed

Łęczna, 21-010, Poland

Location

Related Publications (1)

  • Wysocki J, Center KJ, Brzostek J, Majda-Stanislawska E, Szymanski H, Szenborn L, Czajka H, Hasiec B, Dziduch J, Jackowska T, Witor A, Kopinska E, Konior R, Giardina PC, Sundaraiyer V, Patterson S, Gruber WC, Scott DA, Gurtman A. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations. Vaccine. 2017 Apr 4;35(15):1926-1935. doi: 10.1016/j.vaccine.2017.02.035. Epub 2017 Mar 3.

    PMID: 28262330DERIVED

Related Links

MeSH Terms

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccineAcetaminophenIbuprofen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 12, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 26, 2014

Results First Posted

February 26, 2014

Record last verified: 2014-01

Locations

PL(14)