Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01446926
First received: October 3, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention Phase
Pneumonia
Pneumococcal Infections
Streptococcus Pneumoniae Infections
Biological: Pneumococcal Vaccine High Dose (Formulation 1)
Biological: Tris buffered saline (Placebo)
Biological: Pneumococcal Vaccine Low Dose (Formulation 2)
Biological: Pneumococcal Vaccine Middle Dose (Formulation 3)
Biological: Pneumococcal Vaccine Middle Dose (Formulation 4)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Immunogenicity of the Pneumococcal Vaccine in adults and toddlers [ Time Frame: Day 30 post-vaccination (adults and toddlers) ] [ Designated as safety issue: No ]
    Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).

  • Immunogenicity of the Pneumococcal Vaccine in toddlers [ Time Frame: Day 30 post-vaccination 2 and 3 (infants) ] [ Designated as safety issue: No ]
    Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).


Enrollment: 280
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Adults High Dose (Formulation 1)
Adults who will receive a single injection of high dose investigational Pneumococcal vaccine
Biological: Pneumococcal Vaccine High Dose (Formulation 1)
0.5 mL, Intramuscular
Placebo Comparator: Group 2: Adults Placebo
Adult participants who will receive an injection of placebo
Biological: Tris buffered saline (Placebo)
0.5 mL, Intramuscular
Other Name: Tris buffered saline
Experimental: Group 3: Toddlers High Dose (Formulation 1)
Toddlers who will receive a single injection of high dose Pneumococcal vaccine
Biological: Pneumococcal Vaccine High Dose (Formulation 1)
0.5 mL, Intramuscular
Placebo Comparator: Group 4: Toddlers Placebo
Toddlers who will receive a single injection of placebo
Biological: Tris buffered saline (Placebo)
0.5 mL, Intramuscular
Other Name: Tris buffered saline
Experimental: Group 5: Infants Low Dose (Formulation 2)
Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine
Biological: Pneumococcal Vaccine Low Dose (Formulation 2)
0.5 mL, Intramuscular
Placebo Comparator: Group 6: Infants Placebo
Infants who will receive 3 injections of placebo
Biological: Tris buffered saline (Placebo)
0.5 mL, Intramuscular
Other Name: Tris buffered saline
Experimental: Group 7: Infants Middle Dose (Formulation 3)
Infants who will receive 3 injections of middle dose Pneumococcal vaccine
Biological: Pneumococcal Vaccine Middle Dose (Formulation 3)
0.5 mL, Intramuscular
Experimental: Group 8: Infants Middle Dose (Formulation 4)
Infants who will receive 3 injections of middle dose Pneumococcal vaccine
Biological: Pneumococcal Vaccine Middle Dose (Formulation 4)
0.5 mL, Intramuscular
Placebo Comparator: Group 9: Infants Placebo
Infants who will receive 3 injections of placebo
Biological: Tris buffered saline (Placebo)
0.5 mL, Intramuscular
Other Name: Tris buffered saline
Experimental: Group 10: Infants High Dose (Formulation 1)
Infants who will receive 3 injections of high dose Pneumococcal vaccine
Biological: Pneumococcal Vaccine High Dose (Formulation 1)
0.5 mL, Intramuscular
Placebo Comparator: Group 11: Infants Placebo
Infants who will receive 3 injections of placebo
Biological: Tris buffered saline (Placebo)
0.5 mL, Intramuscular
Other Name: Tris buffered saline

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446926

Locations
Bangladesh
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01446926     History of Changes
Other Study ID Numbers: PPR02, U1111-1117-7316
Study First Received: October 3, 2011
Last Updated: April 1, 2014
Health Authority: Bangladesh: Directorate of Drug Administration

Keywords provided by Sanofi:
Pneumonia
Pneumococcal Infections
Streptococcus pneumoniae Infections
Pneumococcal vaccines

Additional relevant MeSH terms:
Pneumococcal Infections
Pneumonia
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2014