Pneumococcal Infections
Conditions
Keywords
Nasopharyngeal Colonization, Streptococcus pneumoniae, Healthy Infants, Vaccines, Pneumococcal Conjugate Vaccine
Brief summary
This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
1 dose at 2, 4, 6 and 12 months of age
BIOLOGICAL7 valent pneumococcal conjugate vaccine
1 dose at 2, 4, 6 and 12 months of age
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants aged 2 months (42-98 days) at time of enrolment. * Available for the entire study period and whose parent/legal guardian can be reached by telephone.
Exclusion criteria
* Previous vaccination with licensed or investigational pneumococcal vaccine. * A previous anaphylactic reaction to any vaccine or vaccine-related component. * Contraindication to vaccination with a pneumococcal conjugate vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age | Month 7 through Month 24 | A new acquisition was defined as the detection of a serotype (here 6A' \[6A + 6C\] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 7, 12, 13, 18, 24 |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). | 932 |
| 7vPnC 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). | 934 |
| Total | 1,866 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: Infant Series | Adverse Event | 5 | 4 |
| Period 1: Infant Series | Other | 4 | 1 |
| Period 1: Infant Series | Parent/Legal Guardian Request | 31 | 40 |
| Period 1: Infant Series | Physician Decision | 1 | 0 |
| Period 1: Infant Series | Protocol Violation | 1 | 0 |
| Period 2: After Infant Series | Adverse Event | 2 | 6 |
| Period 2: After Infant Series | Failed to Return | 1 | 0 |
| Period 2: After Infant Series | Lost to Follow-up | 1 | 1 |
| Period 2: After Infant Series | Other | 2 | 1 |
| Period 2: After Infant Series | Parent/Legal Guardian Request | 0 | 3 |
| Period 2: After Infant Series | Protocol Violation | 1 | 0 |
| Period 3: Toddler Dose | Adverse Event | 1 | 0 |
| Period 3: Toddler Dose | Lost to Follow-up | 2 | 3 |
| Period 3: Toddler Dose | Other | 5 | 4 |
| Period 3: Toddler Dose | Parent/Legal Guardian Request | 17 | 8 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age Continuous | 2.2 years STANDARD_DEVIATION 0.3 | 2.2 years STANDARD_DEVIATION 0.3 | 2.2 years STANDARD_DEVIATION 0.3 |
| Sex: Female, Male Female | 474 Participants | 471 Participants | 945 Participants |
| Sex: Female, Male Male | 458 Participants | 463 Participants | 921 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 454 / 930 | 433 / 933 | 290 / 929 | 324 / 931 | 238 / 882 | 240 / 875 | 462 / 882 | 455 / 875 |
| serious Total, serious adverse events | 64 / 930 | 57 / 933 | 48 / 929 | 64 / 931 | 15 / 882 | 23 / 875 | 91 / 882 | 73 / 875 |
Outcome results
Primary
Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age
A new acquisition was defined as the detection of a serotype (here 6A' \[6A + 6C\] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.
Time frame: Month 7 through Month 24
Population: Evaluable culture population included all participants who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC | Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age | 20.0 percentage of participants |
| 7vPnC | Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age | 36.0 percentage of participants |
95% CI: [0.47, 0.65]
Secondary
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age
Time frame: Month 7, 12, 13, 18, 24
Population: Evaluable culture population; 'n' is number of participants with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 13 (n= 871, 870) | 5.4 percentage of participants |
| 13vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 18 (n= 864, 864) | 7.1 percentage of participants |
| 13vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 7 (n= 881, 871) | 7.3 percentage of participants |
| 13vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 12 (n= 881, 873) | 8.1 percentage of participants |
| 13vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 24 (n= 855, 856) | 6.2 percentage of participants |
| 7vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 24 (n= 855, 856) | 10.7 percentage of participants |
| 7vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 13 (n= 871, 870) | 13.6 percentage of participants |
| 7vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 12 (n= 881, 873) | 13.7 percentage of participants |
| 7vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 18 (n= 864, 864) | 13.5 percentage of participants |
| 7vPnC | Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age | Month 7 (n= 881, 871) | 10.9 percentage of participants |
Comparison: Month 7: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.95% CI: [0.5, 0.9]
Comparison: Month 12: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.95% CI: [0.4, 0.7]
Comparison: Month 13: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.95% CI: [0.3, 0.5]
Comparison: Month 18: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.95% CI: [0.4, 0.7]
Comparison: Month 24: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.95% CI: [0.4, 0.8]