Trial Outcomes & Findings for Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali (NCT NCT02286895)

Last Updated: 2019-01-02

Results Overview

Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

600 participants

Primary outcome timeframe

28 days post-vaccination

Results posted on

2019-01-02

Participant Flow

Recruited up to 750 healthy male and female infant subjects of 9-11 months of age from the local communities and community health centers in Bamako, Mali. The duration of planned study participation for each subject was to be approximately 3 months and the estimated duration of the recruitment period was to be 3 months.

Participant milestones

Participant milestones
Measure	Group A (Without Rotavirus Vaccine) Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Randomized and Vaccinated STARTED	300	300
Randomized and Vaccinated COMPLETED	300	300
Randomized and Vaccinated NOT COMPLETED	0	0
Assessed for Measles Seroconversion STARTED	300	300
Assessed for Measles Seroconversion COMPLETED	252	261
Assessed for Measles Seroconversion NOT COMPLETED	48	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A (Without Rotavirus Vaccine) Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Assessed for Measles Seroconversion Protocol Violation	1	4
Assessed for Measles Seroconversion Missing measurement	6	3
Assessed for Measles Seroconversion Baseline measure non-negative	41	32

Baseline Characteristics

Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A (Without Rotavirus Vaccine) n=300 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=300 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Total n=600 Participants Total of all reporting groups
Age, Continuous	9.7 months STANDARD_DEVIATION .7 • n=5 Participants	9.7 months STANDARD_DEVIATION .7 • n=7 Participants	9.7 months STANDARD_DEVIATION .7 • n=5 Participants
Age, Customized 9 months	223 Participants n=5 Participants	224 Participants n=7 Participants	447 Participants n=5 Participants
Age, Customized 10 months	53 Participants n=5 Participants	51 Participants n=7 Participants	104 Participants n=5 Participants
Age, Customized 11 months	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Female	133 Participants n=5 Participants	151 Participants n=7 Participants	284 Participants n=5 Participants
Sex: Female, Male Male	167 Participants n=5 Participants	149 Participants n=7 Participants	316 Participants n=5 Participants
Region of Enrollment Mali	300 participants n=5 Participants	300 participants n=7 Participants	600 participants n=5 Participants
Ethnicity Bambara	101 Participants n=5 Participants	120 Participants n=7 Participants	221 Participants n=5 Participants
Ethnicity Mandika/Malinke	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity Fula/Peulh	49 Participants n=5 Participants	34 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity Sarahule/Sarakole	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity Other	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements and measurement ≤0.90 at baseline (per protocol)

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=252 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=261 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody Seroconversion	246 Participants	255 Participants
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody No seroconversion (≤0.90)	2 Participants	3 Participants
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody Equivocal measurements (≥0.91 and ≤1.09)	4 Participants	3 Participants

PRIMARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements and negative result at baseline (per protocol)

Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known. Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value.

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=290 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=287 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody Seroresponse	153 Participants	141 Participants
Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody No seroresponse	137 Participants	146 Participants

SECONDARY outcome

Timeframe: 3 months post-vaccination

Population: Subjects with valid measurements and measurement ≤0.90 at baseline (per protocol)

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=218 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=228 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody Seroconversion	206 Participants	210 Participants
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody No seroconversion (≤0.90)	4 Participants	5 Participants
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody Equivocal measurements (≥0.91 and ≤1.09)	8 Participants	13 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements (per protocol)

Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice (SOP) and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known.

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine Baseline	2.4 titer Interval 2.3 to 2.5	2.5 titer Interval 2.4 to 2.6
Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine 28 days post-vaccination	16.8 titer Interval 14.8 to 19.1	15 titer Interval 13.3 to 17.0

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements (per protocol)

Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value. Measured using baby rabbit complement (rSBA).

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=292 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA) Seroresponse	276 Participants	273 Participants
Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA) No seroresponse	17 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline to Day 28

Population: Number of subjects with valid measurements (per protocol)

Measured using baby rabbit complement (rSBA).

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=292 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Geometric Mean of Meningitis Serum Bactericidal Antibody Titer	2.8 titer Interval 2.4 to 3.3	3.2 titer Interval 2.7 to 3.9

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements (per protocol)

Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=292 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=292 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value At least 3 times baseline value	80 Participants	131 Participants
Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value Not at least 3 times baseline value	212 Participants	161 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements (per protocol)

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=292 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=292 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL ≥20 Units/mL	172 Participants	218 Participants
Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL <20 Units/mL	120 Participants	74 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Participants with valid measures of anti-rotavirus IgA \<20 units/mL at baseline

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=165 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=160 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 Seroresponse	52 Participants	91 Participants
Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 No seroresponse	113 Participants	69 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value Seroresponse	77 Participants	168 Participants
Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value No seroresponse	216 Participants	125 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements (per protocol)

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL ≥20 Units/mL	223 Participants	275 Participants
Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL <20 Units/mL	70 Participants	18 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Participants with valid measures of anti-rotavirus IgA \<20 units/mL at baseline

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=92 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=91 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 Seroresponse	29 Participants	76 Participants
Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 No seroresponse	63 Participants	15 Participants

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements (per protocol)

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=292 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=292 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Geometric Mean of Anti-rotavirus IgA Concentration Baseline	23.7 titer Interval 18.6 to 30.3	25.3 titer Interval 19.7 to 32.6
Geometric Mean of Anti-rotavirus IgA Concentration 28 days post-vaccination	67.9 titer Interval 49.9 to 92.3	118.4 titer Interval 90.9 to 154.3

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Number of subjects with valid measurements (per protocol)

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=293 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Geometric Mean of Anti-rotavirus IgG Concentration Baseline	58.9 titer Interval 47.1 to 73.7	62.5 titer Interval 49.6 to 78.8
Geometric Mean of Anti-rotavirus IgG Concentration 28 days post-vaccination	153.3 titer Interval 113.8 to 206.5	363.6 titer Interval 293.6 to 450.4

SECONDARY outcome

Timeframe: 28 days post-vaccination

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=165 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=160 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline Baseline	5.1 titer Interval 4.7 to 5.5	4.8 titer Interval 4.4 to 5.1
Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline 28 days post-vaccination	22.2 titer Interval 15.2 to 32.6	41.5 titer Interval 29.8 to 57.9

SECONDARY outcome

Timeframe: 28 days post-vaccination

Population: Participants with valid measures of anti-rotavirus IgG \<20 units/mL at baseline

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=92 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=91 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline Baseline	7.8 titer Interval 6.9 to 8.9	7.4 titer Interval 6.5 to 8.4
Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline 28 days post-vaccination	28.3 titer Interval 16.3 to 49.2	123.7 titer Interval 83.1 to 184.2

SECONDARY outcome

Timeframe: Within 30 minutes post-vaccination

Population: Among all subjects enrolled (intent-to-treat population)

With emphasis on allergic reactions, observed by study staff

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=300 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=300 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination Any immediate reaction	0 Participants	0 Participants
Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination No immediate reaction	300 Participants	300 Participants

SECONDARY outcome

Timeframe: 7 days post-vaccination

identified or observed by study staff during home visits and/or reported by a parent at any time. Solicited adverse reactions were graded and sub-categorized as those deemed related to vaccination or not by the investigator.

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=41 systemic reaction Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=38 systemic reaction Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number of Solicited Adverse Reactions (AR) Experienced by Participants Diarrhea	24 systemic reaction	21 systemic reaction
Number of Solicited Adverse Reactions (AR) Experienced by Participants Vomiting	8 systemic reaction	7 systemic reaction
Number of Solicited Adverse Reactions (AR) Experienced by Participants Pyrexia	5 systemic reaction	8 systemic reaction
Number of Solicited Adverse Reactions (AR) Experienced by Participants Irritability	1 systemic reaction	2 systemic reaction
Number of Solicited Adverse Reactions (AR) Experienced by Participants Lethargy	2 systemic reaction	0 systemic reaction
Number of Solicited Adverse Reactions (AR) Experienced by Participants Rash	1 systemic reaction	0 systemic reaction

SECONDARY outcome

Timeframe: 3 months post-vaccination

Population: Among all subjects enrolled (intent-to-treat population)

Occurring from vaccination through 3 months post-vaccination, identified or observed by study staff and/or reported by a parent at any time. Serious adverse events were graded for severity and sub-categorized as those deemed related to vaccination or not by the investigator.

Outcome measures

Outcome measures
Measure	Group A (Without Rotavirus Vaccine) n=300 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=300 Participants Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Number/Percentage of Participants Experiencing Serious Adverse Events (SAE) At least 1 SAE probably related to vaccination	1 Participants	0 Participants
Number/Percentage of Participants Experiencing Serious Adverse Events (SAE) At least 1 SAE not related to vaccination	6 Participants	7 Participants
Number/Percentage of Participants Experiencing Serious Adverse Events (SAE) No SAE	292 Participants	293 Participants
Number/Percentage of Participants Experiencing Serious Adverse Events (SAE) 1 SAE unlikely to be related to vaccination	1 Participants	0 Participants

Adverse Events

Group A (Without Rotavirus Vaccine)

Serious events: 8 serious events

Other events: 125 other events

Deaths: 0 deaths

Group B (With Rotavirus Vaccine)

Serious events: 7 serious events

Other events: 103 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group A (Without Rotavirus Vaccine) n=300 participants at risk Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg). measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly	Group B (With Rotavirus Vaccine) n=300 participants at risk Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV). pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly
Gastrointestinal disorders Gastroenteritis	0.67% 2/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.	0.67% 2/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.
Infections and infestations Bronchitis	0.67% 2/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.	0.00% 0/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.
Infections and infestations Malaria	0.33% 1/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.	1.7% 5/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.
Infections and infestations Pharyngitis	0.33% 1/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.	0.00% 0/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.
Infections and infestations Pneumonia	0.33% 1/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.	0.00% 0/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.
Injury, poisoning and procedural complications Burns second degree	0.33% 1/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.	0.00% 0/300 • 3 months post-vaccination (death and serious adverse events), 28 days (all other adverse events) Field staff members visited study subjects on Days 1 through 5 to inquire about specific local and systemic signs and symptoms. On Day 7, a physician visited the subject's home for evaluation. Subjects returned to the study center on Day 28 and Day 84 for evaluation. After Day 28, only SAEs (with the exception of signs of potential intussusception) did not require documentation. A malaria test was conducted on Days 0, 28, and 84.

Other adverse events

Additional Information

Jorge Flores

PATH

Phone: (202) 822-0033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place