Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
Status: | Recruiting |
---|---|
Conditions: | Pneumonia, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 3/1/2019 |
Start Date: | June 1, 2018 |
End Date: | June 9, 2020 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel
design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal
vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent
pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent
pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a
single dose of multivalent pneumococcal conjugate vaccine (Group 3).
design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal
vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent
pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent
pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a
single dose of multivalent pneumococcal conjugate vaccine (Group 3).
Inclusion Criteria:
- Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days)
at the time of consent (the day of birth is considered day of life 1).
- Healthy infant determined by medical history, physical examination, and clinical
judgment.
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Prior receipt of routine pediatric vaccines, with the exception of hepatitis B
vaccine.
- Previous receipt of >1 dose of hepatitis B vaccine.
- Prior hepatitis B vaccine must have been administered at age <30 days.
- Major known congenital malformation or serious chronic disorder.
- Receipt of blood/plasma products or immunoglobulins.
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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