Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
Safety and Immunogenicity of Pneumococcal Protein Vaccine (PPrV) in Healthy Adults, Toddlers and Infants in Bangladesh
2 other identifiers
interventional
280
1 country
1
Brief Summary
This study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment. Primary Objective:
- To evaluate the safety and tolerability of an investigational pneumococcal vaccine. Secondary Objective:
- To evaluate the immunogenicity of an investigational pneumococcal vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 10, 2018
January 1, 2018
1.5 years
October 3, 2011
January 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and percentage of participants reporting solicited injection site and systemic reactions, unsolicited systemic reactions, and serious adverse events following vaccination.
Solicited injection site reactions: For adults: Pain, Erythema, and Swelling; Toddlers and infants: Tenderness, Erythema, Swelling. Solicited systemic reactions: For adults, Fever (Temperature), Headache, Malaise, and Myalgia; Toddlers and infants, Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.
Day 0 through Day 90 post-vaccination
Secondary Outcomes (2)
Immunogenicity of the Pneumococcal Vaccine in adults and toddlers
Day 30 post-vaccination (adults and toddlers)
Immunogenicity of the Pneumococcal Vaccine in toddlers
Day 30 post-vaccination 2 and 3 (infants)
Study Arms (11)
Group 1: Adults High Dose (Formulation 1)
EXPERIMENTALAdults who will receive a single injection of high dose investigational Pneumococcal vaccine
Group 2: Adults Placebo
PLACEBO COMPARATORAdult participants who will receive an injection of placebo
Group 3: Toddlers High Dose (Formulation 1)
EXPERIMENTALToddlers who will receive a single injection of high dose Pneumococcal vaccine
Group 4: Toddlers Placebo
PLACEBO COMPARATORToddlers who will receive a single injection of placebo
Group 5: Infants Low Dose (Formulation 2)
EXPERIMENTALInfants who will receive 3 injections of low dose low dose Pneumococcal vaccine
Group 6: Infants Placebo
PLACEBO COMPARATORInfants who will receive 3 injections of placebo
Group 7: Infants Middle Dose (Formulation 3)
EXPERIMENTALInfants who will receive 3 injections of middle dose Pneumococcal vaccine
Group 8: Infants Middle Dose (Formulation 4)
EXPERIMENTALInfants who will receive 3 injections of middle dose Pneumococcal vaccine
Group 9: Infants Placebo
PLACEBO COMPARATORInfants who will receive 3 injections of placebo
Group 10: Infants High Dose (Formulation 1)
EXPERIMENTALInfants who will receive 3 injections of high dose Pneumococcal vaccine
Group 11: Infants Placebo
PLACEBO COMPARATORInfants who will receive 3 injections of placebo
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Adults:
- Informed consent form has been signed and dated. If the subject is unable to read the informed consent form, a site-defined standard procedure will be followed to ensure subject understanding of the process and will be marked by the subject and signed by a witness.
- Able to attend all scheduled visits and to comply with all trial procedures.
- Infants and Toddlers:
- Born at full term of pregnancy (≥37 weeks) and having a weight ≥ 60% of the median weight for Bangladesh as measured by the "weight-to-length" index.
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations). If the subject's parent(s) or other legally acceptable representative is unable to read the informed consent form, a procedure will be followed to ensure his/her understanding of the process and will be marked by the subject's parent(s) or other legally acceptable representative and signed by a witness.
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
You may not qualify if:
- (Adults only): Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).
- Participation or planned participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination except if non-interventional follow-up for an earlier study (e.g., long-term surveillance).
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, or planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Previous vaccination against S. pneumoniae (in the previous 5 years).
- History of pneumococcal infection (confirmed microbiologically) within 5 years.
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol abuse or drug addiction.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- (Adults only): Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
- (Infants and Toddlers only): Parents or guardians identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
- Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Dhaka, 1212, Bangladesh
Related Publications (1)
Brooks WA, Chang LJ, Sheng X, Hopfer R; PPR02 Study Team. Safety and immunogenicity of a trivalent recombinant PcpA, PhtD, and PlyD1 pneumococcal protein vaccine in adults, toddlers, and infants: A phase I randomized controlled study. Vaccine. 2015 Aug 26;33(36):4610-7. doi: 10.1016/j.vaccine.2015.06.078. Epub 2015 Jul 2.
PMID: 26143615RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 5, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
January 10, 2018
Record last verified: 2018-01