Trial Outcomes & Findings for Ad26.ZEBOV Booster in Children Previously Vaccinated With Ad26.ZEBOV and MVA-BN-Filo (EBOVAC Booster Study) (NCT NCT04711356)
NCT ID: NCT04711356
Last Updated: 2023-12-13
Results Overview
Number and percentage of participants with at least one solicited local adverse event (i.e. pain, erythema, pruritus and swelling)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
From the booster vaccination to 7 days post booster
Results posted on
2023-12-13
Participant Flow
Participants were screened between 8 July and 18 August 2021 at one clinic in Kambia Town, located in Kambia District in the North West Province of Sierra Leone.
All the enrolled participants received the study intervention.
Participant milestones
| Measure |
Study Intervention
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ad26.ZEBOV Booster in Children Previously Vaccinated With Ad26.ZEBOV and MVA-BN-Filo (EBOVAC Booster Study)
Baseline characteristics by cohort
| Measure |
Study Intervention
n=50 Participants
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection
|
|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Sierra Leone
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the booster vaccination to 7 days post boosterPopulation: All participants who had received the Ad26.ZEBOV booster
Number and percentage of participants with at least one solicited local adverse event (i.e. pain, erythema, pruritus and swelling)
Outcome measures
| Measure |
Study Intervention
n=50 Participants
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection.
|
|---|---|
|
Number of Participants With Solicited Local (at the Administration Site) Adverse Events
|
18 Participants
|
PRIMARY outcome
Timeframe: From the booster vaccination to 7 days post boosterPopulation: All participants who had received the Ad26.ZEBOV booster
Number and percentage of participants with at least one solicited systemic adverse event (i.e. arthralgia, chills, fatigue, headache, myalgia, nausea and pyrexia)
Outcome measures
| Measure |
Study Intervention
n=50 Participants
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection.
|
|---|---|
|
Number of Participants With Solicited Systemic Adverse Events
|
16 Participants
|
PRIMARY outcome
Timeframe: From the booster vaccination to 28 days post boosterPopulation: All participants who had received the Ad26.ZEBOV booster
Number and percentage of participants with at least one unsolicited adverse event
Outcome measures
| Measure |
Study Intervention
n=50 Participants
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection.
|
|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
32 Participants
|
PRIMARY outcome
Timeframe: From the booster vaccination to 28 days post boosterPopulation: All participants who had received the Ad26.ZEBOV booster
Number and percentage of participants with serious adverse events
Outcome measures
| Measure |
Study Intervention
n=50 Participants
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection.
|
|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
PRIMARY outcome
Timeframe: day 1 before booster administrationPopulation: All boosted participants who had at least one evaluable post-booster sample and had no major protocol deviations that could have influenced the immune response after booster vaccination.
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Outcome measures
| Measure |
Study Intervention
n=49 Participants
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection.
|
|---|---|
|
Pre-booster Baseline Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
|
640 ELISA units/mL
Interval 461.0 to 888.0
|
PRIMARY outcome
Timeframe: At 7 days post boosterPopulation: All boosted participants who had an evaluable post-booster sample and had no major protocol deviations that could have influenced the immune response after booster vaccination.
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Outcome measures
| Measure |
Study Intervention
n=50 Participants
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection.
|
|---|---|
|
Vaccine-induced Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
|
28561 ELISA units/mL
Interval 20255.0 to 40272.0
|
PRIMARY outcome
Timeframe: At 21 days post boosterPopulation: All boosted participants who had an evaluable post-booster sample and had no major protocol deviations that could have influenced the immune response after booster vaccination
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Outcome measures
| Measure |
Study Intervention
n=49 Participants
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection.
|
|---|---|
|
Vaccine-induced Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
|
64690 ELISA units/mL
Interval 48356.0 to 86541.0
|
Adverse Events
Study Intervention
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Intervention
n=50 participants at risk
Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection
|
|---|---|
|
Infections and infestations
Malaria
|
50.0%
25/50 • Number of events 25 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Infections and infestations
Upper respiratory tract infections
|
14.0%
7/50 • Number of events 7 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Infections and infestations
Lower respiratory tract infection/pneumonia
|
8.0%
4/50 • Number of events 4 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Infections and infestations
Rhinitis
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Infections and infestations
Worm infestation
|
4.0%
2/50 • Number of events 2 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Infections and infestations
Acute otitis media
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Infections and infestations
Scabies
|
4.0%
2/50 • Number of events 2 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
2/50 • Number of events 2 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Blood and lymphatic system disorders
Thrombocytopaenia
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Vascular disorders
Leg ulcer
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Injury, poisoning and procedural complications
Eye burns
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Gastrointestinal disorders
Dental caries
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
General disorders
Swollen thumb
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/50 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Skin and subcutaneous tissue disorders
Pain
|
36.0%
18/50 • Number of events 18 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • Number of events 1 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
0.00%
0/50 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
General disorders
Chills
|
12.0%
6/50 • Number of events 6 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
General disorders
Fatigue
|
16.0%
8/50 • Number of events 8 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
General disorders
Headache
|
22.0%
11/50 • Number of events 11 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/50 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • Number of events 3 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
|
General disorders
Pyrexia
|
12.0%
6/50 • Number of events 6 • Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
|
Additional Information
Dr Daniela Manno, clinical trial coordinator and responsible physician
London School of Hygiene & Tropical Medicine
Phone: +44 20 7927
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place