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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Napoli, Campania, 80122 Italy
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
75-105 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Aged 3 months (75 to 105 days) at time of enrollment.

2. Available for entire study period and whose parent(s)/legal guardian(s) could be
reached by telephone.

3. Healthy infant, as determined by medical history, physical examination, and judgment
of the investigator.

4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless
of gestational age and birth weight, all subjects must have met inclusion criterion
number 3.

5. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures
during study participation.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Previous vaccination with licensed or investigational pneumococcal vaccine.

2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or
hepatitis B vaccines.

3. A previous anaphylactic reaction to any vaccine or vaccine-related component.

4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, or hepatitis B, or pneumococcal vaccines.

5. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

6. Known or suspected immune deficiency or suppression.

7. History of culture-proven invasive disease caused by S pneumoniae or Hib.

8. Major known congenital malformation or serious chronic disorder.

9. 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. Did not include resolving syndromes due
to birth trauma such as Erb palsy.

10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and
monoclonal antibodies; eg, Synagis® [MedImmune]).

11. Participation in another investigational trial. Participation in purely observational
studies was acceptable.

12. Infant who was a direct descendant (eg, child or grandchild) of the study site
personnel.

NCT00366899
Pfizer
Completed
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety,Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in Italy
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vaccines, Pneumococcal
  • Biological: 13-valent pneumococcal conjugate vaccine
    Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
  • Biological: 7 valent pneumococcal conjugate vaccine
    Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
  • Experimental: 1
    13-valent pneumococcal conjugate vaccine
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: 2
    7-valent pneumococcal conjugate vaccine
    Intervention: Biological: 7 valent pneumococcal conjugate vaccine
Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinón-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
605
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Aged 3 months (75 to 105 days) at time of enrollment.
  2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
  3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
  4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.
  5. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression.
  7. History of culture-proven invasive disease caused by S pneumoniae or Hib.
  8. Major known congenital malformation or serious chronic disorder.
  9. 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. Did not include resolving syndromes due to birth trauma such as Erb palsy.
  10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis® [MedImmune]).
  11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
  12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Sexes Eligible for Study: All
75 Days to 105 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00366899
6096A1-500
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Italy, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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