A Phase 4, Open-label Trial Describing the Safety, Tolerability, and Immunogenicity of the 13 valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants

• Register: EUCTR
• Last refreshed on: 10 March 2014
• Main ID: EUCTR2009-017332-41-PL
• Date of registration: 17/08/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York NY10017
• Public title: A Phase 4, Open-label Trial Describing the Safety, Tolerability, and Immunogenicity of the 13 valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants
• Scientific title: A Phase 4, Open-label Trial Describing the Safety, Tolerability, and Immunogenicity of the 13 valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants
• Date of first enrolment: 14/09/2010
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017332-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Poland, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
Group 1 Preterm infants:
1. Male or female infant born at < 37 weeks of gestation (GA as determined by the investigator).
2. Chronological age = 42 to = 98 days (approximately 2 months) at the time of enrollment.
3. Otherwise healthy preterm infant as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
5. Available for the entire study period and whose parent/ legal guardian can be reached by telephone.

Group 2 Term infants:
1. Male or female infant born at = 37 weeks of gestation (GA as determined by the investigator).
2. Chronological age = 42 to = 98 days (approximately 2 months) at the time of enrollment.
3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
5. Available for the entire study period and whose parent/ legal guardian can be reached by telephone.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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, Hib conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
2. A previous anaphylactic reaction or allergy to any vaccine or vaccine-related component.
3. Contraindication to vaccination with any routine pediatric vaccines.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. History of culture-proven invasive disease caused by S pneumoniae.
6. Known or suspected immune deficiency or immune suppression.
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 disorder.
9. Receipt of any other investigational vaccines, drugs, or medical devices within 28 days before inclusion and the first study vaccination.
10. Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
11. Major illness or conditions that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in, and completion of, the study, or could preclude the evaluation of the subject’s response.


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

Health Condition(s) or Problem(s) studied

Pneumococcal infection
MedDRA version: 14.1 Level: PT Classification code 10061353 Term: Pneumococcal infection 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-
INN or Proposed INN: 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
Concentrat

Primary Outcome(s)

Main Objective: To describe the pneumococcal immune response induced by 13vPnC when measured 1 month after the infant series in preterm infants compared to term infants (= 37 weeks of gestation).

Secondary Objective: To describe the pneumococcal immune response induced by 13vPnC when measured 1 month after the toddler dose in preterm infants compared to term infants (= 37 weeks of gestation).

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

Secondary ID(s)

6096A1-4001-EU

2009-017332-41-ES