Trial Outcomes & Findings for Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth (NCT NCT00992836)

Last Updated: 2021-11-05

Results Overview

Shows the number of participants who had at least one adverse event (AE) in each category. The AEs include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

155 participants

Primary outcome timeframe

Measured up to 7 months after vaccination

Results posted on

2021-11-05

Participant Flow

Participants were enrolled from 37 sites between October 14, 2009 and November 12, 2009. Participants were stratified by age in three groups: \>=4 to \< 9 years old, \>=9 to \< 18 years old and \>=18 to \<25 years old.

One study participant was inadvertently enrolled with acute illness, was not given any vaccination and was immediately taken off study. A second study participant received the first vaccination but it was discovered that he/she was not compliant with the ARV regimen and was taken off study before receiving the second dose of vaccine.

Participant milestones

Participant milestones
Measure	All Study Participants Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
Overall Study STARTED	155
Overall Study Received Both Study Vaccinations	150
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	2

Baseline Characteristics

Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=155 Participants Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
Age, Continuous	13 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants
Region of Enrollment United States	147 participants n=5 Participants
Region of Enrollment Puerto Rico	8 participants n=5 Participants
Age Strata >=4 to < 9 years old	54 Participants n=5 Participants
Age Strata >=9 to < 18 years old	51 Participants n=5 Participants
Age Strata >=18 to < 25 years old	50 Participants n=5 Participants
CD4 Cells Count	568 cells / mm^3 STANDARD_DEVIATION 242 • n=5 Participants
Percentage of CD4 Cells	29 percentage STANDARD_DEVIATION 11 • n=5 Participants

PRIMARY outcome

Timeframe: Measured up to 7 months after vaccination

Outcome measures

Outcome measures
Measure	All Study Participants n=155 Participants All 155 study participants are included in this analysis.
The Number of Participants Who Had at Least One Adverse Event (AE) Overall (New AEs after start of treatment)	113 participants
The Number of Participants Who Had at Least One Adverse Event (AE) Grade 4 AEs (New, after start of treatment)	0 participants
The Number of Participants Who Had at Least One Adverse Event (AE) Grade 3 AEs (New, after start of treatment)	7 participants
The Number of Participants Who Had at Least One Adverse Event (AE) Grade 2 local and systemic AEs to injection	6 participants

PRIMARY outcome

Timeframe: Measured up to 7 months after vaccination

Population: The 154 study participants who received at last one vaccination are included in this analysis.

Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.

Outcome measures

Outcome measures
Measure	All Study Participants n=154 Participants All 155 study participants are included in this analysis.
The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine	7 participants

PRIMARY outcome

Timeframe: Measured at Day 21

Population: The 154 study participants who received at last one vaccination are included in this analysis.

Outcome measures

Outcome measures
Measure	All Study Participants n=154 Participants All 155 study participants are included in this analysis.
Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose	0 participants

PRIMARY outcome

Timeframe: Measured at 21 days after first dose and 10 days after second dose

Population: The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.

Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were \<10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640 and \>=1280. Seroprotection was defined as having a titer of \>=40 following vaccination.

Outcome measures

Outcome measures
Measure	All Study Participants n=142 Participants All 155 study participants are included in this analysis.
Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40 Post dose 1 (N=140)	72.1 percentage of participants Interval 63.9 to 79.4
Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40 Post dose 2 (N=142)	82.4 percentage of participants Interval 75.1 to 88.3

SECONDARY outcome

Timeframe: Measured at 6 months after second dose

Population: The HAI titers were summarized for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.

Outcome measures

Outcome measures
Measure	All Study Participants n=138 Participants All 155 study participants are included in this analysis.
Percent of Participants With an HAI Titer >=40 at Long-term Follow-up	57.2 percentage of participants Interval 48.5 to 65.6

SECONDARY outcome

Timeframe: Measured after first and second doses and 6 months after second dose

Presents the value of the geometric mean titer at each time point.

Outcome measures

Outcome measures
Measure	All Study Participants n=142 Participants All 155 study participants are included in this analysis.
Geometric Mean Antibody Titers (GMT) HAI At 21 days after the first vaccination (N=140)	85 titers Interval 65.0 to 111.0
Geometric Mean Antibody Titers (GMT) HAI At 10 days after the second vaccination (N=142)	127 titers Interval 101.0 to 159.0
Geometric Mean Antibody Titers (GMT) HAI At 6 months after the second vaccination (N=138)	33 titers Interval 27.0 to 40.0

SECONDARY outcome

Timeframe: Measured at entry, 21 days after first dose, and 10 days after second dose

Population: The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.

The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10\^6 peripheral blood mononucleated cell (PBMC) and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10\^6 PBMC.

Outcome measures

Outcome measures
Measure	All Study Participants n=68 Participants All 155 study participants are included in this analysis.
Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values IgG ASC/10^6 PBMC, Week 0 (N=46)	6 ASC or SFC/10^6 PBMC Interval 2.0 to 16.0
Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values IgG ASC/10^6 PBMC, Post Dose 1 (N=40)	13 ASC or SFC/10^6 PBMC Interval 4.0 to 40.0
Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values IgG ASC/10^6 PBMC, Post Dose 2 (N=40)	12 ASC or SFC/10^6 PBMC Interval 5.0 to 25.0
Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values pH1N1 IFNgamma SFC/10^6 PBMC, Week 0 (N=68)	317 ASC or SFC/10^6 PBMC Interval 117.0 to 673.0
Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values pH1N1 IFNgamma SFC/10^6 PBMC, Post Dose 1 (N=68)	363 ASC or SFC/10^6 PBMC Interval 123.0 to 622.0
Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values pH1N1 IFNgamma SFC/10^6 PBMC, Post Dose 2 (N=65)	261 ASC or SFC/10^6 PBMC Interval 78.0 to 525.0

SECONDARY outcome

Timeframe: Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose

Population: The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.

Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were \<10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and \>=1280.

Outcome measures

Outcome measures
Measure	All Study Participants n=123 Participants All 155 study participants are included in this analysis.
HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV) Week 0 (N=123)	40 titer Interval 20.0 to 80.0
HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV) Post Dose 1 (N=121)	40 titer Interval 20.0 to 80.0
HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV) Post Dose 2 (N=121)	40 titer Interval 20.0 to 80.0
HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV) 6 months Post Dose 2 (N=122)	40 titer Interval 20.0 to 80.0

SECONDARY outcome

Timeframe: Measured at entry, 21 days after first dose, and 10 days after second dose

Population: The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.

The TIV assay was not performed due to lack of available cells after completion of other planned assays. The median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 Granzyme B spot-forming cells (SFC)/10\^6 peripheral blood mononucleated cell (PBMC). The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA INFgamma spot-forming cells (SFC)/10\^6 PBMC. The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA Granzyme B spot-forming cells (SFC)/10\^6 PBMC.

Outcome measures

Outcome measures
Measure	All Study Participants n=68 Participants All 155 study participants are included in this analysis.
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens pH1N1 Granzyme B SFC/10^6 PBMC, Week 0 (N=64)	35 SFC/10^6 PBMC Interval 0.0 to 220.0
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens pH1N1 Granzyme B SFC/10^6 PBMC, Week 3 (N=62)	26 SFC/10^6 PBMC Interval 0.0 to 170.0
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens pH1N1 Granzyme B SFC/10^6 PBMC, Week 5 (N=61)	30 SFC/10^6 PBMC Interval 0.0 to 220.0
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens PHA INFgamma SFC/10^6 PBMC, Week 0 (N=68)	699 SFC/10^6 PBMC Interval 307.0 to 1010.0
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens PHA INFgamma SFC/10^6 PBMC, Week 3 (N=68)	637 SFC/10^6 PBMC Interval 261.0 to 965.0
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens PHA INFgamma SFC/10^6 PBMC, Week 5 (N=65)	624 SFC/10^6 PBMC Interval 263.0 to 1000.0
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens PHA Granzyme B SFC/10^6 PBMC, Week 0 (N=64)	3250 SFC/10^6 PBMC Interval 390.0 to 7465.0
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens PHA Granzyme B SFC/10^6 PBMC, Week 3 (N=62)	3340 SFC/10^6 PBMC Interval 510.0 to 7520.0
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens PHA Granzyme B SFC/10^6 PBMC, Week 5 (N=60)	2045 SFC/10^6 PBMC Interval 300.0 to 7825.0

Adverse Events

All Study Participants

Serious events: 6 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Study Participants n=155 participants at risk Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
Blood and lymphatic system disorders Neutropenia	0.65% 1/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
General disorders Gait disturbance	0.65% 1/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Infections and infestations Herpes zoster	0.65% 1/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Musculoskeletal and connective tissue disorders Muscular weakness	0.65% 1/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Nervous system disorders Syncope	0.65% 1/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Nervous system disorders VIIth nerve paralysis	0.65% 1/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.

Other adverse events

Other adverse events
Measure	All Study Participants n=155 participants at risk Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
Ear and labyrinth disorders Ear pain	6.5% 10/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Gastrointestinal disorders Abdominal pain	7.1% 11/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Gastrointestinal disorders Diarrhoea	10.3% 16/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Gastrointestinal disorders Nausea	7.7% 12/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Gastrointestinal disorders Vomiting	11.6% 18/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
General disorders Adverse event	12.9% 20/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
General disorders Fatigue	7.1% 11/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
General disorders Pyrexia	12.3% 19/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Infections and infestations Otitis media	7.1% 11/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Investigations Alanine aminotransferase increased	7.1% 11/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Investigations Aspartate aminotransferase increased	5.8% 9/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Investigations Neutrophil count decreased	13.5% 21/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 12/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Nervous system disorders Headache	18.7% 29/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Respiratory, thoracic and mediastinal disorders Cough	32.9% 51/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Respiratory, thoracic and mediastinal disorders Nasal congestion	22.6% 35/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.6% 32/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	12.3% 19/155 • Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination. Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: 919-405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place