A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine given as a series of 2 infant doses and 1 toddler dose in healthy infants

Phase 3

Completed

• Conditions: 10043413; infections caused by the pneumococ bacteria; Pneumococcal Infections

• Registration Number: NL-OMON49743
• Lead Sponsor: Pfizer

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-03-11
• Results First Posted: 2022-10-08
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

Section 5.1 in protocol
1. Male or female infants born at >36 weeks of gestation and 2 months of age
(*42 to *112 days) at the time of consent (the day of birth is considered day
of life 1).
2. Participants whose parent(s)/legal guardian(s) are willing and able to
comply with all scheduled visits, treatment plan, and other study procedures.
3. Healthy infants determined by clinical assessment, including medical history
and clinical judgment, to be eligible for the study.
4. Expected to be available for the duration of the study and whose
parents(s)/legal guardian can be contacted by telephone during study
participation.
5. Participants whose parent(s)/legal guardian(s) is capable of giving signed
informed consent as described in Appendix 1, which includes compliance with the
requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria

Section 5.2 in protocol

1. History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of investigational product
or any diphtheria toxoid*containing vaccine.
2. 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 and/or
hypotonic-hyporesponsive episodes.
3. Major known congenital malformation or serious chronic disorder
4. History of microbiologically proven invasive disease caused by S pneumonia
5. Known or suspected immunodeficiency or other conditions associated with
immunosuppression, including, but not limited to, immunoglobulin class/subclass
deficiencies, DiGeorge syndrome, generalized malignancy, human immunodeficiency
virus (HIV) infection, leukemia, lymphoma, or organ or bone marrow transplant.
6. Bleeding diathesis or condition associated with prolonged bleeding that
would, in the opinion of the investigator, contraindicate intramuscular
injection.
7. Congenital, functional, or surgical asplenia
8. Other 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
participant inappropriate for entry into this study.
9. Previous vaccination with any licensed or investigational pneumococcal
vaccine, or planned receipt through study participation.
10. Prior receipt of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib
vaccine
11. Currently receives treatment with immunosuppressive therapy, including
cytotoxic agents or systemic corticosteroids, or planned receipt through the
last blood draw. If systemic corticosteroids have been administered short term
(<14 days) for treatment of an acute illness, participants should not be
enrolled into the study until corticosteroid therapy has been discontinued for
at least 28 days before investigational product administration.
Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or
ears) corticosteroids are permitted.
12. Receipt of blood/plasma products or immunoglobulins (including hepatitis B
immunoglobulin) since birth or planned receipt through the last planned blood
draw in the study (Visit 5, 13-month visit).
13. Participation in other studies involving investigational drug(s),
investigational vaccines, or investigational devices within 28 days prior to
study entry and/or during study participation or intrauterine exposure to
investigational vaccines. Participation in purely observational studies is
acceptable.
14. Children or grandchildren who are direct descendants of investigator site
staff members or Pfizer employees who are directly involved in the conduct of
the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified