Cholera Vaccine, Live, for Oral Administration
Name: Cholera Vaccine, Live, for Oral Administration
Side effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
The safety of VAXCHORA was evaluated in four randomized, placebo-controlled, multicenter clinical trials. A total of 3235 adults 18 through 64 years of age received one dose of VAXCHORA and 562 received placebo [physiologic saline (N=551) or lactose (N=11)]. Overall, the mean age was 32.5 years; 53.8% of trial participants were female; 67.1% were White, 27.3% were Black or African American, 1.8% were Asian, 1.7% were multiracial, 1.3% were other, 0.6% were American Indian or Alaskan Native and 0.3% were Native Hawaiian or Pacific Islander. There were 9.3% Hispanic or Latino participants.
Solicited Adverse ReactionsAdults 18 through 45 years of age received VAXCHORA in a multi-center, double-blind, randomized (8:1), placebo-controlled trial conducted in the United States and Australia (Study 1). The safety analysis set included 2789 VAXCHORA recipients. Solicited adverse reactions were recorded daily for 7 days following vaccination. Table 1 presents the frequency and severity of solicited adverse reactions observed within 7 days following receipt of VAXCHORA or placebo in Study 1.
Table 1: Rates of Solicited Adverse Reactions Reported in VAXCHORA Trial Participants 18 to 64 Years of Age During 7 Days Post-Vaccination
| Adverse Reaction | Study 1a | |
| VAXCHORA (N=2789)b % | Placebo (Saline) (N=350)b % | |
| Tiredness | 31.3 | 27.4 |
| Mild | 18.7 | 16.3 |
| Moderate | 12.0 | 9.9 |
| Severec | 0.7 | 1.2 |
| Headache | 28.9 | 23.6 |
| Mild | 18.9 | 14.6 |
| Moderate | 9.6 | 8.8 |
| Severec | 0.5 | 0.3 |
| Abdominal Pain | 18.7 | 16.9 |
| Mild | 12.1 | 12.0 |
| Moderate | 6.2 | 5.0 |
| Severec | 0.4 | 0.0 |
| Nausea/Vomiting | 18.3 | 15.2 |
| Mild | 13.3 | 11.4 |
| Moderate | 4.7 | 3.8 |
| Severec | 0.3 | 0.0 |
| Lack of Appetite | 16.5 | 16.6 |
| Mild | 11.7 | 12.2 |
| Moderate | 4.4 | 4.4 |
| Severec | 0.3 | 0.0 |
| Diarrhea | 3.9 | 1.2 |
| Mild | 2.4 | 0.9 |
| Moderate | 0.7 | 0.3 |
| Severec | 0.84 | 0.0 |
| Fever | 0.6 | 1.2 |
| Mild | 0.2 | 0.3 |
| Moderate | 0.3 | 0.9 |
| Severec | 0.11 | 0.0 |
| a Data are derived from Study 1 (NCT02094586). b N represents number of subjects who completed a memory aid. c Severe category includes both grade 3 (severe) and grade 4 (potentially life-threatening) adverse events Grading scales are defined as follows: Tiredness , Headache, Abdominal Pain, Nausea, Lack of Appetite: Mild = no interference with activity, Moderate = Some interference with activity, Severe = significant, prevents daily activity, Potentially Life Threatening = emergency room (ER) visit or hospitalization. Vomiting: Mild = 1-2 episodes/24 hours, Moderate = > 2 episodes/24 hours, Severe = requires intravenous hydration, Potentially Life Threatening = ER visit or hospitalization for hypotensive shock. Diarrhea: Mild = 4 loose stools/24 hours, Moderate = 5 loose stools/24 hours, Severe = ≥ 6 loose stools /24 hours, Potentially Life Threatening = ER visit or hospitalization. Fever: Mild = 38.0-38.4°C/100.4-101.1°F, Moderate = 38.5-38.9°C/101.2-102.0°F, Severe = 39.0-40.0°C/102.1-104.0°F, Potentially Life Threatening = > 40.0 °C/104.0 °F. | ||
In a pooled analysis of the four clinical studies, 0.6% (20/3235) of VAXCHORA recipients and 0.5% (3/562) of placebo recipients reported a serious adverse event within 6 months post-vaccination. None of these events were considered to be related to vaccination.