Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

• Register: EUCTR
• Last refreshed on: 8 April 2013
• Main ID: EUCTR2010-022303-22-PL
• Date of registration: 07/06/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
• Public title: Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
• Scientific title: A PHASE 4, RANDOMIZED, OPEN-LABEL TRIAL TO ASSESS THE IMPACT OF PROPHYLACTIC ANTIPYRETIC MEDICATION ON THE IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH ROUTINE PEDIATRIC VACCINATIONS IN HEALTHY INFANTS
• Date of first enrolment: 22/06/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022303-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Comparing antipyretics Number of treatment arms in the trial: 5

Countries of recruitment

Poland

Contacts

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the subject’s parent/legal guardian has been informed of all pertinent aspects of the study.
2. Aged 2 months (=56 to =98 days) at time of enrollment (day of birth is considered to be day 1 in this study).
3. Available for entire study period and whose parent/legal guardian can be reached by telephone.
4. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
5. Parent/legal guardian is able to complete all relevant study procedures during study participation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 908
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the study:
1. Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Allergy or contraindication to paracetamol or ibuprofen administration including known renal disease or anomaly that may increase the risk associated with administration of ibuprofen (including clinically significant vesiculoureteral reflux, anatomic abnormality, etc).
4. Chronic use of any medications with known drug interactions with paracetamol or ibuprofen.
5. Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.
6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
7. Known or suspected immune deficiency or suppression.
8. History of culture-proven invasive disease caused by S pneumoniae.
9. Major known congenital malformation or serious chronic disorder.
10. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma, such as Erb’s palsy.
11. Receipt of blood products or gamma-globulin within 12 weeks before the first dose of 13vPnC until the blood draw approximately 1 month after the last dose of 13vPnC.
12. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
13. Receipt of any investigational drugs or medical devices within 28 days before the first dose of 13vPnC until the blood draw approximately 1 month after the last dose of 13vPnC.
14. Subject is a direct descendent (child or grandchild) of any study personnel or Pfizer employee.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Pneumonia and ear infections caused by S pneumoniae.
MedDRA version: 14.1 Level: LLT Classification code 10042194 Term: Streptococcus pneumoniae meningitis System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1 Level: LLT Classification code 10042195 Term: Streptococcus pneumoniae pneumonia System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1 Level: LLT Classification code 10042197 Term: Streptococcus pneumoniae septicaemia System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Trade Name: Prevenar 13
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 8.8-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
CAS Number: 0
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A
Concentration unit: µg/ml microgram(s)/millilitre
Concent

Primary Outcome(s)

Primary end point(s): The serotype specific IgG geometric mean concentrations (GMCs) for each of the
pneumococcal serotypes measured 1 month after the infant series.

Main Objective: To assess the impact of prophylactic paracetamol or ibuprofen administration on the
immunogenicity of 13vPnC as measured by serotype-specific IgG geometric mean
concentrations (GMCs) after completion of the infant series.

Secondary Objective: ? To assess the impact of prophylactic paracetamol or ibuprofen administration on the immunogenicity of 13vPnC as measured by serotype-specific IgG geometric mean
concentrations (GMCs) after the toddler dose.
? To assess the impact of prophylactic paracetamol or ibuprofen administration on the immunogenicity of 13vPnC as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) in a subset of subjects after completion
of the infant series.
? To assess the impact of prophylactic paracetamol or ibuprofen administration on the immunogenicity of Infanrix hexa as measured by geometric mean antibody
concentrations/titers (GMCs/GMTs) to INFANRIX hexa antigens after completion of the infant series and after the toddler dose.

Timepoint(s) of evaluation of this end point: Visit 4 and Visit 6

Secondary Outcome(s)

Secondary end point(s): The proportion of subjects achieving a serotype specific IgG antibody concentration =0.35 µg/mL for each of the pneumococcal serotypes measured 1 month after the infant series.

Timepoint(s) of evaluation of this end point: Visit 4 and Visit 6

Secondary ID(s)

B1851047

Source(s) of Monetary Support

Pfizer Inc