A clinical study to test the safety, tolerability and immune response of a vaccine against pneumococcal bacteria, presented in a multidose vial given with other vaccines to healthy infants.

• Register: EUCTR
• Last refreshed on: 16 February 2015
• Main ID: EUCTR2012-000482-21-Outside-EU/EEA
• Date of registration: 10/02/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc
• Public title: A clinical study to test the safety, tolerability and immune response of a vaccine against pneumococcal bacteria, presented in a multidose vial given with other vaccines to healthy infants.
• Scientific title: A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE FORMULATED IN MULTIDOSE VIALS GIVEN WITH ROUTINE PEDIATRIC VACCINATIONS IN HEALTHY INFANTS
• Target sample size: 500
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000482-21
• 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: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Gambia

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject’s parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study. If the subject’s parent(s)/legal guardian(s) is illiterate they must thumbprint the ICD and it must be signed and dated by an impartial witness who was present throughout the entire informed consent process.
2. Aged 42 to 70 days at time of enrollment.
3. Available for entire study period.
4. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
5. Parent(s)/legal guardian(s) is willing and able to comply with scheduled visits and other study procedures.
6. Weight of 3.5 kg or greater at the time of enrollment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 500
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:
1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal conjugate vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by Streptococcus pneumoniae.
7. Major known congenital malformation or serious chronic disorder.
8. 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.
9. Receipt of blood products or gamma-globulin since birth and until the blood draw approximately 1 month after the last dose of 13vPnC.
10. 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.
11. Participation in other studies within 28 days before the current study begins and/or during study participation. Participation in observational studies, and interventional studies such as those where a nasopharyngeal swab or urine sample may be collected, are permitted.
12. Subjects who are direct descendents (child or grandchild) of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.


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

Health Condition(s) or Problem(s) studied

MedDRA version: 17.1 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations

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

Intervention(s)

Product Name: 13-valent pneumococcal conjugate vaccine in a multidose vial
Product Code: PF-06414256
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 2.2-4.4

Trade Name: Prevenar 13
Product Name: 13-valent pneumococcal conjugate vaccine
Product Code: PF-05208760
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 2.2 -4.4

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: One month after completion of the infant series of injections.

Secondary Objective: To assess the immune response induced by 13vPnC with 2-phenoxyethanol in multidose vials relative to the immune response induced by 13vPnC without 2-phenoxyethanol in single-dose syringes as measured by serotype-specific opsonophagocytic activity (OPA).

Main Objective: To demonstrate that the immune response induced by 13vPnC with 2-phenoxyethanol in multidose vials (MDVs) is noninferior to the immune response induced by 13vPnC without 2-phenoxyethanol in single-dose syringes (SDSs) as measured by serotype-specific immunoglobulin G (IgG) concentrations 1 month after the infant series.

Primary end point(s): - The percentage of subjects achieving a serotype-specific IgG antibody concentration greater than or equal to 0.35 mcg/mL for each of the pneumococcal serotypes measured 1 month after the
infant series for each vaccine group.
- The serotype-specific IgG geometric mean concentration (GMC) for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group (MDV group or SDS group).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: One month after completion of the infant series of injections.

Secondary end point(s): - The proportion of subjects in a subset achieving a serotype-specific OPA titer greater than or equal to the lower
limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group.
- The serotype-specific OPA geometric mean titer (GMT) for each of the pneumococcal serotypes 1 month after the infant series for each vaccine group.

Secondary ID(s)

B4671001

Source(s) of Monetary Support

Pfizer Inc