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

Primary Purpose

Pneumonia, Pneumococcal Infections, Streptococcus Pneumoniae Infections

Status
Completed
Phase
Phase 1
Locations
Bangladesh
Study Type
Interventional
Intervention
Pneumococcal Vaccine High Dose (Formulation 1)
Tris buffered saline (Placebo)
Pneumococcal Vaccine High Dose (Formulation 1)
Tris buffered saline (Placebo)
Pneumococcal Vaccine Low Dose (Formulation 2)
Tris buffered saline (Placebo)
Pneumococcal Vaccine Middle Dose (Formulation 3)
Pneumococcal Vaccine Middle Dose (Formulation 4)
Tris buffered saline (Placebo)
Pneumococcal Vaccine High Dose (Formulation 1)
Tris buffered saline (Placebo)
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring Pneumonia, Pneumococcal Infections, Streptococcus pneumoniae Infections, Pneumococcal vaccines

Eligibility Criteria

6 Weeks - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group 1: Adults High Dose (Formulation 1)

Group 2: Adults Placebo

Group 3: Toddlers High Dose (Formulation 1)

Group 4: Toddlers Placebo

Group 5: Infants Low Dose (Formulation 2)

Group 6: Infants Placebo

Group 7: Infants Middle Dose (Formulation 3)

Group 8: Infants Middle Dose (Formulation 4)

Group 9: Infants Placebo

Group 10: Infants High Dose (Formulation 1)

Group 11: Infants Placebo

Arm Description

Adults who will receive a single injection of high dose investigational Pneumococcal vaccine

Adult participants who will receive an injection of placebo

Toddlers who will receive a single injection of high dose Pneumococcal vaccine

Toddlers who will receive a single injection of placebo

Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine

Infants who will receive 3 injections of placebo

Infants who will receive 3 injections of middle dose Pneumococcal vaccine

Infants who will receive 3 injections of middle dose Pneumococcal vaccine

Infants who will receive 3 injections of placebo

Infants who will receive 3 injections of high dose Pneumococcal vaccine

Infants who will receive 3 injections of placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Immunogenicity of the Pneumococcal Vaccine in adults and toddlers
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Immunogenicity of the Pneumococcal Vaccine in toddlers
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).

Full Information

First Posted
October 3, 2011
Last Updated
January 9, 2018
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01446926
Brief Title
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
Official Title
Safety and Immunogenicity of Pneumococcal Protein Vaccine (PPrV) in Healthy Adults, Toddlers and Infants in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumococcal Infections, Streptococcus Pneumoniae Infections
Keywords
Pneumonia, Pneumococcal Infections, Streptococcus pneumoniae Infections, Pneumococcal vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Adults High Dose (Formulation 1)
Arm Type
Experimental
Arm Description
Adults who will receive a single injection of high dose investigational Pneumococcal vaccine
Arm Title
Group 2: Adults Placebo
Arm Type
Placebo Comparator
Arm Description
Adult participants who will receive an injection of placebo
Arm Title
Group 3: Toddlers High Dose (Formulation 1)
Arm Type
Experimental
Arm Description
Toddlers who will receive a single injection of high dose Pneumococcal vaccine
Arm Title
Group 4: Toddlers Placebo
Arm Type
Placebo Comparator
Arm Description
Toddlers who will receive a single injection of placebo
Arm Title
Group 5: Infants Low Dose (Formulation 2)
Arm Type
Experimental
Arm Description
Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine
Arm Title
Group 6: Infants Placebo
Arm Type
Placebo Comparator
Arm Description
Infants who will receive 3 injections of placebo
Arm Title
Group 7: Infants Middle Dose (Formulation 3)
Arm Type
Experimental
Arm Description
Infants who will receive 3 injections of middle dose Pneumococcal vaccine
Arm Title
Group 8: Infants Middle Dose (Formulation 4)
Arm Type
Experimental
Arm Description
Infants who will receive 3 injections of middle dose Pneumococcal vaccine
Arm Title
Group 9: Infants Placebo
Arm Type
Placebo Comparator
Arm Description
Infants who will receive 3 injections of placebo
Arm Title
Group 10: Infants High Dose (Formulation 1)
Arm Type
Experimental
Arm Description
Infants who will receive 3 injections of high dose Pneumococcal vaccine
Arm Title
Group 11: Infants Placebo
Arm Type
Placebo Comparator
Arm Description
Infants who will receive 3 injections of placebo
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine High Dose (Formulation 1)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Tris buffered saline (Placebo)
Other Intervention Name(s)
Tris buffered saline
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine High Dose (Formulation 1)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Tris buffered saline (Placebo)
Other Intervention Name(s)
Tris buffered saline
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine Low Dose (Formulation 2)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Tris buffered saline (Placebo)
Other Intervention Name(s)
Tris buffered saline
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine Middle Dose (Formulation 3)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine Middle Dose (Formulation 4)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Tris buffered saline (Placebo)
Other Intervention Name(s)
Tris buffered saline
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine High Dose (Formulation 1)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Tris buffered saline (Placebo)
Other Intervention Name(s)
Tris buffered saline
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number and percentage of participants reporting solicited injection site and systemic reactions, unsolicited systemic reactions, and serious adverse events following vaccination.
Description
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.
Time Frame
Day 0 through Day 90 post-vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity of the Pneumococcal Vaccine in adults and toddlers
Description
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Day 30 post-vaccination (adults and toddlers)
Title
Immunogenicity of the Pneumococcal Vaccine in toddlers
Description
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Day 30 post-vaccination 2 and 3 (infants)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
26143615
Citation
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.
Results Reference
result

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

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