Immune Response to Rotavirus Vaccine After a Supplemental... | NCT02286895

Name	Class
Center for Vaccine Development - Mali	OTHER
University of Maryland	OTHER

Label	Type	Description	Intervention Names
Group A (without rotavirus vaccine)	Active Comparator	Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg).	Biological: measles vaccine (MV) Biological: yellow fever vaccine (YFV) Biological: meningitis conjugate vaccine (PsA-TT-5μg)
Group B (with rotavirus vaccine)	Experimental	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).	Biological: pentavalent rotavirus vaccine (PRV) Biological: measles vaccine (MV) Biological: yellow fever vaccine (YFV) Biological: meningitis conjugate vaccine (PsA-TT-5μg)

Name	Type	Description	Arm Group Labels	Other Names
pentavalent rotavirus vaccine (PRV)	Biological	Each two-ml dose contains 5 live human-bovine reassortant rotaviruses with a minimum of 2.0 - 2.8 x 106 infectious units (IU) per reassortant, depending on the serotype, and not greater than 116 x 106 IU per aggregate dose. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives. RotaTeq is a pale yellow clear liquid that may have a pink tint. This vaccine was administered orally.

Measure	Description	Time Frame
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody	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	28 days post-vaccination
Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody	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.	28 days post-vaccination

Measure	Description	Time Frame
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody	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.	3 months post-vaccination

Name	Affiliation	Role
Samba O Sow, MD, Msc	Center for Vaccine Development - Mali	Principal Investigator

PubMed Identifier	Type	Citation	Retractions
29659924	Derived	Haidara FC, Tapia MD, Sow SO, Doumbia M, Coulibaly F, Diallo F, Traore A, Kodio M, Kelly CL, Fitzpatrick M, Kotloff K, Victor JC, Neuzil K. Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants. J Infect Dis. 2018 Jul 13;218(4):606-613. doi: 10.1093/infdis/jiy215.

ID	Title	Description
FG000	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

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000300 BG001300 BG002600

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody

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

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

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000252 OG001261

Title

Denominators

Categories

Title	Measurements
Seroconversion	OG000246 OG001255
No seroconversion (≤0.90)	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Based on results from a prior study, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.					Mean Difference (Net)	0.1			2-Sided	95	-4.0	4.2					Non-Inferiority	The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was > -10%.

Primary

Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody

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.

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

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody

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

Posted

Count of Participants

Participants

3 months post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine

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.

Number of subjects with valid measurements (per protocol)

Posted

Geometric Mean

95% Confidence Interval

titer

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA)

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

Number of subjects with valid measurements (per protocol)

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Geometric Mean of Meningitis Serum Bactericidal Antibody Titer

Measured using baby rabbit complement (rSBA).

Number of subjects with valid measurements (per protocol)

Posted

Geometric Mean

95% Confidence Interval

titer

Baseline to Day 28

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value

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.

Number of subjects with valid measurements (per protocol)

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL

Number of subjects with valid measurements (per protocol)

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28

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

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL

Number of subjects with valid measurements (per protocol)

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28

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

Posted

Count of Participants

Participants

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Geometric Mean of Anti-rotavirus IgA Concentration

Number of subjects with valid measurements (per protocol)

Posted

Geometric Mean

95% Confidence Interval

titer

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Geometric Mean of Anti-rotavirus IgG Concentration

Number of subjects with valid measurements (per protocol)

Posted

Geometric Mean

95% Confidence Interval

titer

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline

Posted

Mean

95% Confidence Interval

titer

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline

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

Posted

Geometric Mean

95% Confidence Interval

titer

28 days post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination

With emphasis on allergic reactions, observed by study staff

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

Posted

Count of Participants

Participants

Within 30 minutes post-vaccination

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Solicited Adverse Reactions (AR) Experienced by Participants

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.

Posted

Count of Units

systemic reaction

7 days post-vaccination

systemic reaction

ID	Title	Description
OG000	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
OG001	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

Secondary

Number/Percentage of Participants Experiencing Serious Adverse Events (SAE)

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.

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

Posted

Count of Participants

Participants

3 months post-vaccination

ID	Title	Description
OG000	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
OG001	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

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastroenteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected300 at risk EG0012 affected300 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected300 at risk EG0010 affected300 at risk
Malaria	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0015 affected300 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected300 at risk EG0010 events0 affected300 at risk
Otitis media	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Otitis media acute	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0005 affected300 at risk EG0016 affected300 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected300 at risk EG0012 affected300 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00041 affected300 at risk EG00130 affected300 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected300 at risk EG0016 affected300 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected300 at risk EG0017 affected300 at risk
Irritability	General disorders	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0012 affected300 at risk
Lethargy	General disorders	MedDRA	Systematic Assessment	EG0002 affected300 at risk EG0010 affected300 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0005 affected300 at risk EG0018 affected300 at risk
Allergic respiratory symptoms	Immune system disorders	MedDRA	Systematic Assessment	EG00032 affected300 at risk EG00121 affected300 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0013 affected300 at risk
Candida infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Ear infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected300 at risk EG0011 affected300 at risk
Impetigo	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected300 at risk EG0010 affected300 at risk
Malaria	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected300 at risk EG0017 affected300 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected300 at risk EG0018 affected300 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected300 at risk EG0015 affected300 at risk
Rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG00061 affected300 at risk EG00155 affected300 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected300 at risk EG0012 affected300 at risk
Varicella	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Impetigo	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected300 at risk EG0010 affected300 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected300 at risk EG0011 affected300 at risk
Wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0011 affected300 at risk
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected300 at risk EG0010 affected300 at risk

ID	Term
C492535	RotaTeq
D008458	Measles Vaccine
D022341	Yellow Fever Vaccine

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	300	8	300	125	300
EG001	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	0	300	7	300	103	300