Trial Outcomes & Findings for Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074) (NCT NCT04481191)

Last Updated: 2024-07-26

Results Overview

The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

400 participants

Primary outcome timeframe

Baseline and 1 month postdose 3 of IPV (Month ~3.5)

Results posted on

2024-07-26

Participant Flow

This study was conducted at a study center in China.

Participant milestones

Participant milestones
Measure	Concomitant RotaTeq and IPV Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Overall Study STARTED	200	200
Overall Study ≥1 V260 Vaccination	189	200
Overall Study COMPLETED	185	190
Overall Study NOT COMPLETED	15	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Concomitant RotaTeq and IPV Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Overall Study Withdrawn by parent/guardian	15	10

Baseline Characteristics

Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concomitant RotaTeq and IPV n=200 Participants Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=200 Participants Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Total n=400 Participants Total of all reporting groups
Age, Continuous	53.3 days STANDARD_DEVIATION 4.8 • n=5 Participants	53.3 days STANDARD_DEVIATION 4.6 • n=7 Participants	53.3 days STANDARD_DEVIATION 4.7 • n=5 Participants
Age, Customized Infants and toddlers (48 to 63 days)	200 Participants n=5 Participants	200 Participants n=7 Participants	400 Participants n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	93 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	107 Participants n=7 Participants	221 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	200 Participants n=5 Participants	200 Participants n=7 Participants	400 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	200 Participants n=5 Participants	200 Participants n=7 Participants	400 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 month postdose 3 of IPV (Month ~3.5)

Population: Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.

Outcome measures

Outcome measures
Measure	Concomitant RotaTeq and IPV n=180 Participants Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=187 Participants Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 1	98.9 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 2	98.3 Percentage of Participants	99.5 Percentage of Participants
Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 3	100.0 Percentage of Participants	99.5 Percentage of Participants

SECONDARY outcome

Timeframe: 1 month postdose 3 of IPV (Month ~3.5)

The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.

Outcome measures

Outcome measures
Measure	Concomitant RotaTeq and IPV n=180 Participants Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=187 Participants Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 1	5600.80 Titers 95% Confidence Interval 4898.46 • Interval 4898.46 to 6403.85	5344.24 Titers 95% Confidence Interval 4657.51 • Interval 4657.51 to 6132.22
Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 2	1059.83 Titers 95% Confidence Interval 951.13 • Interval 951.13 to 1180.96	1122.43 Titers 95% Confidence Interval 1002.74 • Interval 1002.74 to 1256.41
Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 3	3405.56 Titers 95% Confidence Interval 3033.93 • Interval 3033.93 to 3822.71	3261.69 Titers 95% Confidence Interval 2913.70 • Interval 2913.7 to 3651.24

SECONDARY outcome

Timeframe: 1 month post dose 3 of IPV (Month ~3.5)

The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.

Outcome measures

Outcome measures
Measure	Concomitant RotaTeq and IPV n=180 Participants Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=187 Participants Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 1	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 3	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 2	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0

SECONDARY outcome

Timeframe: 1 month postdose 3 of IPV (Month ~3.5)

The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.

Outcome measures

Outcome measures
Measure	Concomitant RotaTeq and IPV n=180 Participants Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=187 Participants Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 1	100.00 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 2	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV Poliovirus Type 3	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0	100.0 Percentage of Participants 95% Confidence Interval 98.0 • Interval 98.0 to 100.0

SECONDARY outcome

Timeframe: Up to 7 days following each IPV vaccination

Population: All participants who received ≥1 dose of study treatment are included.

Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.

Outcome measures

Outcome measures
Measure	Concomitant RotaTeq and IPV n=189 Participants Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=200 Participants Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Percentage of Participants With Solicited Injection-Site Adverse Events	25.4 Percentage of Participants	23.0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 7 days following each RotaTeq and/or IPV vaccination

Population: All participants who received ≥1 dose of study treatment and have data available are included.

Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).

Outcome measures

Outcome measures
Measure	Concomitant RotaTeq and IPV n=189 Participants Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=200 Participants Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Percentage of Participants With Solicited Systemic Adverse Events Elevated temperature	12.3 Percentage of Participants	16.3 Percentage of Participants
Percentage of Participants With Solicited Systemic Adverse Events Diarrhoea	13.2 Percentage of Participants	21.5 Percentage of Participants
Percentage of Participants With Solicited Systemic Adverse Events Vomiting	10.6 Percentage of Participants	19.5 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 3.5 months

Population: All participants who received ≥1 dose of study treatment are included.

The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.

Outcome measures

Outcome measures
Measure	Concomitant RotaTeq and IPV n=189 Participants Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=200 Participants Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Percentage of Participants With Serious Adverse Events (SAEs)	3.7 Percentage of Participants	5.5 Percentage of Participants

Adverse Events

Concomitant RotaTeq and IPV

Serious events: 7 serious events

Other events: 123 other events

Deaths: 0 deaths

Staggered RotaTeq and IPV

Serious events: 11 serious events

Other events: 143 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Concomitant RotaTeq and IPV n=189 participants at risk Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=200 participants at risk Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Gastrointestinal disorders Enteritis	0.00% 0/189 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.50% 1/200 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Bronchitis	1.6% 3/189 • Number of events 3 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.00% 0/200 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Epididymitis	0.00% 0/189 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.50% 1/200 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Gastrointestinal viral infection	0.00% 0/189 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.50% 1/200 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Influenza	0.00% 0/189 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.50% 1/200 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Pneumonia	1.6% 3/189 • Number of events 3 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	3.0% 6/200 • Number of events 6 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Septic shock	0.00% 0/189 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.50% 1/200 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Upper respiratory tract infection	0.00% 0/189 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.50% 1/200 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Nervous system disorders Motor developmental delay	0.53% 1/189 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.00% 0/200 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Pneumonia aspiration	0.00% 0/189 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.50% 1/200 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/189 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	0.50% 1/200 • Number of events 1 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.

Other adverse events

Other adverse events
Measure	Concomitant RotaTeq and IPV n=189 participants at risk Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).	Staggered RotaTeq and IPV n=200 participants at risk Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Gastrointestinal disorders Diarrhoea	17.5% 33/189 • Number of events 43 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	25.0% 50/200 • Number of events 77 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Gastrointestinal disorders Dyspepsia	5.3% 10/189 • Number of events 13 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	6.5% 13/200 • Number of events 14 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Gastrointestinal disorders Vomiting	10.6% 20/189 • Number of events 23 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	19.5% 39/200 • Number of events 66 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
General disorders Injection site erythema	23.8% 45/189 • Number of events 62 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	20.5% 41/200 • Number of events 45 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
General disorders Injection site pain	6.3% 12/189 • Number of events 14 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	3.5% 7/200 • Number of events 7 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
General disorders Pyrexia	15.9% 30/189 • Number of events 33 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	18.5% 37/200 • Number of events 48 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Bronchitis	4.2% 8/189 • Number of events 9 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	6.5% 13/200 • Number of events 14 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Upper respiratory tract infection	16.4% 31/189 • Number of events 40 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	18.0% 36/200 • Number of events 41 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Respiratory, thoracic and mediastinal disorders Cough	10.1% 19/189 • Number of events 26 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	7.0% 14/200 • Number of events 16 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	9.0% 17/189 • Number of events 18 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	9.0% 18/200 • Number of events 20 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Skin and subcutaneous tissue disorders Eczema	7.4% 14/189 • Number of events 14 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	6.0% 12/200 • Number of events 18 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.
Infections and infestations Nasopharyngitis	7.4% 14/189 • Number of events 14 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.	7.0% 14/200 • Number of events 16 • Up to approximately 3.5 months All participants who received ≥1 study-related vaccination are included.

Additional Information

Clinical Trials Disclosure

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER