Trial Outcomes & Findings for Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV) (NCT NCT05175014)
NCT ID: NCT05175014
Last Updated: 2024-12-05
Results Overview
The effect of a single dose PCV10 campaign in the reduction of VT carriage will be assessed by: first, assessing the superiority of a campaign using full doses of PCV10 compared to control group without vaccination; and second, by establishing the non-inferiority of a campaign using fractional doses of PCV10 compared to a campaign using full doses. NP carriage will be measured in the 3 study arms (full dose arm, fractional dose arm and control arm) in a baseline survey implemented prior to the vaccination campaign and in a post-vaccination survey. The NP carriage of VT S. pneumoniae will be measured as the proportion of participants that are colonized with any of the 10 serotypes covered by PCV10 at each time point. The reduction in NP carriage will be calculated by comparing the proportion of children carrying VT pneumococci 6 months post-vaccination to baseline, at the time of vaccination. The prevalence of colonization of non-VT serotypes will also be described at both timepoints.
COMPLETED
PHASE4
44618 participants
During three months of vaccination campaign, and 6 months post-vaccination campaign
2024-12-05
Participant Flow
In the lead-in to the study, the total number of participants living in the 63 clusters was estimated to be approximately 32000. After study initiation, more accurate population figures were obtained, leading to the actual 44618 participants described in the reported results.
Unit of analysis: Clusters
Participant milestones
| Measure |
Single Full Dose of PCV 10
27 clusters randomized to receive a vaccination campaign with the full dose.
PCV10 full dose: Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.
|
Single Fractional Dose of PCV10 (1/5)
27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5).
PCV10 fractional dose: Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.
|
Control Group
9 clusters randomized to the control arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20091 27
|
18821 27
|
5706 9
|
|
Overall Study
COMPLETED
|
20091 27
|
18821 27
|
5706 9
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Full Dose of PCV 10
n=955 Participants
27 clusters randomized to receive a vaccination campaign with the full dose.
PCV10 full dose: Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.
|
Single Fractional Dose of PCV10 (1/5)
n=948 Participants
27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5).
PCV10 fractional dose: Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.
|
Control Group
n=320 Participants
9 clusters randomized to the control arm.
|
Total
n=2223 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
4.5 years
STANDARD_DEVIATION 0.5 • n=955 Participants
|
4.3 years
STANDARD_DEVIATION 0.6 • n=948 Participants
|
4.5 years
STANDARD_DEVIATION 0.6 • n=320 Participants
|
4.4 years
STANDARD_DEVIATION 0.6 • n=2223 Participants
|
|
Sex: Female, Male
Female
|
482 Participants
n=955 Participants
|
473 Participants
n=948 Participants
|
157 Participants
n=320 Participants
|
1112 Participants
n=2223 Participants
|
|
Sex: Female, Male
Male
|
473 Participants
n=955 Participants
|
475 Participants
n=948 Participants
|
163 Participants
n=320 Participants
|
1111 Participants
n=2223 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Niger
|
955 participants
n=955 Participants
|
948 participants
n=948 Participants
|
320 participants
n=320 Participants
|
2223 participants
n=2223 Participants
|
|
Baseline prevalence of VT pneumococcal carriage
|
15.6 Percentage of participants
n=955 Participants
|
17.9 Percentage of participants
n=948 Participants
|
18.8 Percentage of participants
n=320 Participants
|
17.0 Percentage of participants
n=2223 Participants
|
PRIMARY outcome
Timeframe: During three months of vaccination campaign, and 6 months post-vaccination campaignPopulation: Outcome is the percentage of participants with vaccine-type pneumococal carriage in the clusters
The effect of a single dose PCV10 campaign in the reduction of VT carriage will be assessed by: first, assessing the superiority of a campaign using full doses of PCV10 compared to control group without vaccination; and second, by establishing the non-inferiority of a campaign using fractional doses of PCV10 compared to a campaign using full doses. NP carriage will be measured in the 3 study arms (full dose arm, fractional dose arm and control arm) in a baseline survey implemented prior to the vaccination campaign and in a post-vaccination survey. The NP carriage of VT S. pneumoniae will be measured as the proportion of participants that are colonized with any of the 10 serotypes covered by PCV10 at each time point. The reduction in NP carriage will be calculated by comparing the proportion of children carrying VT pneumococci 6 months post-vaccination to baseline, at the time of vaccination. The prevalence of colonization of non-VT serotypes will also be described at both timepoints.
Outcome measures
| Measure |
Single Full Dose of PCV 10
n=27 Clusters
27 clusters randomized to receive a vaccination campaign with the full dose.
PCV10 full dose: Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.
|
Single Fractional Dose of PCV10 (1/5)
n=27 Clusters
27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5).
PCV10 fractional dose: Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.
|
Control Group
n=9 Clusters
9 clusters randomized to the control arm.
|
|---|---|---|---|
|
Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage
|
4.6 Percentage of participants
|
8.0 Percentage of participants
|
16.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28 days after vaccinationVaccine safety will be monitored up to 28 days after vaccination and all AEs and SAEs will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 2 years of study start.An age-structured, dynamic, deterministic model of pneumococcal transmission will be constructed to estimate the impact of mass fractional dose PCV campaigns on VT carriage. The model will use the data on social interactions between age groups and PCV coverage estimates collected during the baseline survey as well as the results of the VT carriage from the baseline survey. Based on the modeled epidemiological impact of PCV10 mass campaigns, with both full and fractional doses, a cost-effectiveness analysis will be performed to estimate the incremental cost-effectiveness ratio of routine PCV10 mass campaigns. The modeled epidemiological impact and cost-effectiveness of a fractional dose mass campaign will be used to inform ongoing discussions of dose-sparing strategies and the use of single-dose fractional PCV in acute humanitarian emergencies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 2 years of study start.A qualitative study will be conducted among parents, healthcare workers, national and international stakeholders to develop insights and recommendations on how a potential future fractional dose PCV mass campaign could be successfully planned, communicated, delivered and integrated into national immunization programs.
Outcome measures
Outcome data not reported
Adverse Events
Single Full Dose of PCV 10
Single Fractional Dose of PCV10 (1/5)
Control Group
Serious adverse events
| Measure |
Single Full Dose of PCV 10
n=20091 participants at risk
27 clusters randomized to receive a vaccination campaign with the full dose.
PCV10 full dose: Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.
|
Single Fractional Dose of PCV10 (1/5)
n=18821 participants at risk
27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5).
PCV10 fractional dose: Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.
|
Control Group
n=5706 participants at risk
9 clusters randomized to the control arm.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
1/20091 • Number of events 1 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.00%
0/18821 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.02%
1/5706 • Number of events 1 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
|
Infections and infestations
Gastroenteritis
|
0.01%
2/20091 • Number of events 2 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.03%
5/18821 • Number of events 5 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.02%
1/5706 • Number of events 1 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
|
Infections and infestations
Malaria
|
0.09%
18/20091 • Number of events 18 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.12%
22/18821 • Number of events 22 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.23%
13/5706 • Number of events 13 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
|
Infections and infestations
Mucocutaneous candidiasis
|
0.00%
1/20091 • Number of events 1 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.00%
0/18821 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.00%
0/5706 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/20091 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.01%
1/18821 • Number of events 1 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.00%
0/5706 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
|
Infections and infestations
Pneumonia
|
0.01%
2/20091 • Number of events 2 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.01%
1/18821 • Number of events 1 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.04%
2/5706 • Number of events 2 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
|
Infections and infestations
Respiratory tract infection
|
0.01%
2/20091 • Number of events 2 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.00%
0/18821 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.00%
0/5706 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
|
Metabolism and nutrition disorders
Kwashiorkor
|
0.01%
2/20091 • Number of events 2 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.02%
3/18821 • Number of events 3 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.04%
2/5706 • Number of events 2 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.00%
0/20091 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.01%
1/18821 • Number of events 1 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
0.00%
0/5706 • Adverse event data were collected for 28 days following vaccination.
Population under surveillance for adverse events is the total population aged 1-9 living in the 63 clusters.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place