- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01446926
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
January 9, 2018 updated by: Sanofi Pasteur, a Sanofi Company
Safety and Immunogenicity of Pneumococcal Protein Vaccine (PPrV) in Healthy Adults, Toddlers and Infants in Bangladesh
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
All adult participants will receive a single injection of study vaccine or placebo.
After satisfactory safety evaluation, toddler participants will receive a single injection of study vaccine or placebo.
After satisfactory safety evaluation, infant participants will receive 3 injections of study vaccine or placebo in dose-ascending order (low, medium, and high dose), with a safety evaluation after each dose level before the study proceeds to the next higher dose.
All participants will undergo immunogenicity testing and monitoring for safety.
Study Type
Interventional
Enrollment (Actual)
280
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dhaka, Bangladesh, 1212
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adults:
- Aged 18 to 50 years on the day of inclusion.
- 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:
- Aged 6 to 7 weeks (42 to 49 days) for infants and 12 to 13 months for toddlers on the day of inclusion
- 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.
Exclusion Criteria:
- (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.
- Bleeding disorder, including thrombocytopenia contraindicating intramuscular (IM) vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Adults High Dose (Formulation 1)
Adults who will receive a single injection of high dose investigational Pneumococcal vaccine
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0.5 mL, Intramuscular
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Placebo Comparator: Group 2: Adults Placebo
Adult participants who will receive an injection of placebo
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0.5 mL, Intramuscular
Other Names:
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Experimental: Group 3: Toddlers High Dose (Formulation 1)
Toddlers who will receive a single injection of high dose Pneumococcal vaccine
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0.5 mL, Intramuscular
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Placebo Comparator: Group 4: Toddlers Placebo
Toddlers who will receive a single injection of placebo
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0.5 mL, Intramuscular
Other Names:
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Experimental: Group 5: Infants Low Dose (Formulation 2)
Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine
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0.5 mL, Intramuscular
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Placebo Comparator: Group 6: Infants Placebo
Infants who will receive 3 injections of placebo
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0.5 mL, Intramuscular
Other Names:
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Experimental: Group 7: Infants Middle Dose (Formulation 3)
Infants who will receive 3 injections of middle dose Pneumococcal vaccine
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0.5 mL, Intramuscular
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Experimental: Group 8: Infants Middle Dose (Formulation 4)
Infants who will receive 3 injections of middle dose Pneumococcal vaccine
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0.5 mL, Intramuscular
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Placebo Comparator: Group 9: Infants Placebo
Infants who will receive 3 injections of placebo
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0.5 mL, Intramuscular
Other Names:
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Experimental: Group 10: Infants High Dose (Formulation 1)
Infants who will receive 3 injections of high dose Pneumococcal vaccine
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0.5 mL, Intramuscular
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Placebo Comparator: Group 11: Infants Placebo
Infants who will receive 3 injections of placebo
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0.5 mL, Intramuscular
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and percentage of participants reporting solicited injection site and systemic reactions, unsolicited systemic reactions, and serious adverse events following vaccination.
Time Frame: Day 0 through Day 90 post-vaccination
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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.
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Day 0 through Day 90 post-vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of the Pneumococcal Vaccine in adults and toddlers
Time Frame: Day 30 post-vaccination (adults and toddlers)
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Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
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Day 30 post-vaccination (adults and toddlers)
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Immunogenicity of the Pneumococcal Vaccine in toddlers
Time Frame: Day 30 post-vaccination 2 and 3 (infants)
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Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
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Day 30 post-vaccination 2 and 3 (infants)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
October 3, 2011
First Submitted That Met QC Criteria
October 3, 2011
First Posted (Estimate)
October 5, 2011
Study Record Updates
Last Update Posted (Actual)
January 10, 2018
Last Update Submitted That Met QC Criteria
January 9, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Pneumonia, Bacterial
- Infections
- Communicable Diseases
- Pneumococcal Infections
- Pneumonia
- Pneumonia, Pneumococcal
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- PPR02
- U1111-1117-7316 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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